New Drug Approvals Archive for 2018

Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: December 20, 2018
Company: Sun Pharma Global
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.

• Sun Pharma Announces FDA Approval of Elepsia XR (levetiracetam) Extended-Release Tablets
• Elepsia XR (levetiracetam) FDA Approval History

Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: December 20, 2018
Company: Sun Pharma Global
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.

• Sun Pharma Advanced Research Company Ltd. Receives Complete Response Letter for Elepsia XR
• Elepsia XR (levetiracetam) FDA Approval History

Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) Tablets

Date of Approval: January 9, 2018
Company: Avion Pharmaceuticals, LLC
Treatment for: Prevention of Pregnancy

Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.

• Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive
• Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) FDA Approval History

Lutathera (lutetium Lu 177 dotatate) Injection

Date of Approval: January 26, 2018
Company: Advanced Accelerator Applications S.A.
Treatment for: Gastroenteropancreatic Neuroendocrine Tumors

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

• FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors
• Lutathera (lutetium Lu 177 dotatate) FDA Approval History

Firvanq (vancomycin hydrochloride) for Oral Solution

Date of Approval: January 26, 2018
Company: CutisPharma
Treatment for: Clostridium Difficile Associated Diarrhea; Enterocolitis

Firvanq (vancomycin hydrochloride) is an oral solution formulation of an approved tricyclic glycopeptide antibiotic for the treatment of Clostridium difficile associated diarrhea and Staphylococcus aureus enterocolitis.

• CutisPharma Announces FDA Approval of Firvanq (vancomycin) for Treatment of Clostridium Difficile Associated Diarrhea and Staphylococcus Aureus Colitis
• Firvanq (vancomycin hydrochloride) FDA Approval History

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: February 7, 2018
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is a combination of an integrase strand transfer inhibitor (bictegravir) and two HIV-1 nucleoside analog reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide) used for the treatment of HIV-1 infection.

• FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection
• Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) FDA Approval History

Dexycu (dexamethasone) Intraocular Suspension

Date of Approval: February 9, 2018
Company: EyePoint Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Dexycu (dexamethasone) is a long-acting, injectable corticosteroid formulation administered intraocularly into the posterior chamber of the eye for the treatment of postoperative inflammation associated with cataract surgery.

• Icon Bioscience Receives FDA Approval for Dexycu (dexamethasone intraocular suspension) for Treating Inflammation Associated With Cataract Surgery
• Dexycu (dexamethasone) FDA Approval History

Symdeko (ivacaftor/tezacaftor and ivacaftor) Tablets

Date of Approval: February 12, 2018
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR) gene that is responsive to Symdeko.

• FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene
• Symdeko (ivacaftor/tezacaftor and ivacaftor) FDA Approval History

Erleada (apalutamide) Tablets

Date of Approval: February 14, 2018
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prostate Cancer

Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of metastatic castration-sensitive prostate cancer, and non-metastatic castration-resistant prostate cancer.

• FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer
• Erleada (apalutamide) FDA Approval History

Osmolex ER (amantadine hydrochloride) Extended-Release Tablets

Date of Approval: February 20, 2018
Company: Osmotica Pharmaceutical US LLC
Treatment for: Parkinson's Disease, Extrapyramidal Reaction

Osmolex ER (amantadine hydrochloride) is a proprietary formulation of immediate release and extended release amantadine for the once-a-day treatment of Parkinson’s disease and drug-induced extrapyramidal reactions.

• FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions
• Osmolex ER (amantadine hydrochloride) FDA Approval History

Apadaz (acetaminophen and benzhydrocodone hydrochloride) Tablets - formerly KP201

Date of Approval: February 23, 2018
Company: KemPharm, Inc.
Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.

• FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain
• Apadaz (acetaminophen and benzhydrocodone hydrochloride) FDA Approval History

ZTlido (lidocaine) Patch - formerly Ztilido

Date of Approval: February 28, 2018
Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia

ZTlido (lidocaine topical system 1.8%) is a transdermal anesthetic formulation for the treatment of pain associated with postherpetic neuralgia.

• Sorrento Therapeutics Subsidiary, Scilex, Receives FDA Approval for Non-Opioid ZTlido (lidocaine topical system) 1.8% for Post-Herpetic Neuralgia Pain
• ZTlido (lidocaine) FDA Approval History

Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: February 5, 2018
Company: Mylan N.V.
Treatment for: HIV Infection

Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

• Mylan to Introduce Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S.
• Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) FDA Approval History

Cimduo (lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: February 28, 2018
Company: Mylan N.V.
Treatment for: HIV Infection

Cimduo (lamivudine and tenofovir disoproxil fumarate) is a combination of two nucleo(t)side reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

• Mylan to Introduce Cimduo (lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S.
• Cimduo (lamivudine and tenofovir disoproxil fumarate) FDA Approval History

Trogarzo (ibalizumab-uiyk) Injection

Date of Approval: March 6, 2018
Company: TaiMed Biologics USA Corp.
Treatment for: HIV Infection

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection.

• FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV
• Trogarzo (ibalizumab-uiyk) FDA Approval History

Ilumya (tildrakizumab-asmn) Injection

Date of Approval: March 20, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Plaque Psoriasis

Ilumya (tildrakizumab-asmn) is a humanized, anti-IL-23p19 monoclonal antibody for the treatment of moderate-to-severe plaque psoriasis.

• FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis
• Ilumya (tildrakizumab-asmn) FDA Approval History

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: March 22, 2018
Company: Mylan N.V.
Treatment for: HIV Infection

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

• Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.
• Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) FDA Approval History

Tavalisse (fostamatinib) Tablets

Date of Approval: April 17, 2018
Company: Rigel Pharmaceuticals, Inc.
Treatment for: Immune Thrombocytopenia

Tavalisse (fostamatinib) is an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of patients with chronic immune thrombocytopenia (ITP).

• FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia
• Tavalisse (fostamatinib) FDA Approval History

Crysvita (burosumab-twza) Injection

Date of Approval: April 17, 2018
Company: Ultragenyx Pharmaceutical Inc.
Treatment for: X-Linked Hypophosphatemia; Tumor-Induced Osteomalacia

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH) and FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO).

• FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
• Crysvita (burosumab-twza) FDA Approval History

Akynzeo for Injection (fosnetupitant and palonosetron)

Date of Approval: April 19, 2018
Company: Helsinn
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Akynzeo for Injection (fosnetupitant and palonosetron) is a substance P/neurokinin-1 (NK-1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist combination indicated for use with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV).

• FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting
• Akynzeo for Injection (fosnetupitant and palonosetron) FDA Approval History

Jynarque (tolvaptan) Tablets

Date of Approval: April 23, 2018
Company: Otsuka Pharmaceutical Co., Ltd.
Treatment for: Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease

Jynarque (tolvaptan) is a selective vasopressin V₂-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

• FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease
• Jynarque (tolvaptan) FDA Approval History

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo)

Date of Approval: May 3, 2018
Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

• FDA Approves Portola Pharmaceuticals’ Andexxa, First and Only Antidote for the Reversal of Factor Xa Inhibitors
• Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) FDA Approval History

Plenvu (polyethylene glycol 3350 with electrolytes) for Oral Solution

Date of Approval: May 4, 2018
Company: Salix Pharmaceuticals, Inc.
Treatment for: Bowel Preparation

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) is a lower-volume, polyethylene glycol based osmotic laxative indicated for cleansing of the colon (bowel preparation) prior to colonoscopy.

• Salix Receives FDA Approval for Plenvu, Next Generation 1-Liter Bowel Cleansing Preparation for Colonoscopies
• Plenvu (polyethylene glycol 3350 with electrolytes) FDA Approval History

Retacrit (epoetin alfa-epbx) for Injection

Date of Approval: May 15, 2018
Company: Hospira Inc.
Treatment for: Anemia

Retacrit (epoetin alfa-epbx) is an erythropoiesis-stimulating agent (ESA) biosimilar to Epogen/Procrit (epoetin alfa) indicated for treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

• FDA Approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the Treatment of Anemia
• Retacrit (epoetin alfa-epbx) FDA Approval History

Lucemyra (lofexidine hydrochloride) Tablets

Date of Approval: May 16, 2018
Company: US WorldMeds
Treatment for: Opiate Withdrawal

Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.

• FDA Approves Lucemyra (lofexidine hydrochloride) as the First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms
• Lucemyra (lofexidine hydrochloride) FDA Approval History

Aimovig (erenumab-aooe) Injection

Date of Approval: May 17, 2018
Company: Amgen Inc.
Treatment for: Migraine Prevention

Aimovig (erenumab-aooe) is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of migraine.

• FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine
• Aimovig (erenumab-aooe) FDA Approval History

Lokelma (sodium zirconium cyclosilicate) for Oral Suspension

Date of Approval: May 18, 2018
Company: AstraZeneca
Treatment for: Hyperkalemia

Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of hyperkalemia in adults.

• FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia
• Lokelma (sodium zirconium cyclosilicate) FDA Approval History

Doptelet (avatrombopag) Tablets

Date of Approval: May 21, 2018
Company: Dova Pharmaceuticals, Inc.
Treatment for: Thrombocytopenia, Immune Thrombocytopenia

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of:

• Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
• Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

• FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure
• Doptelet (avatrombopag) FDA Approval History

Yonsa (abiraterone acetate) Tablets

Date of Approval: May 22, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Prostate Cancer

Yonsa (abiraterone acetate) is an ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) used in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer.

• Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
• Yonsa (abiraterone acetate) FDA Approval History

Palynziq (pegvaliase-pqpz) Injection

Date of Approval: May 24, 2018
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria

Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.

• FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria
• Palynziq (pegvaliase-pqpz) FDA Approval History

Imvexxy (estradiol) Vaginal Inserts - formerly TX-004HR

Date of Approval: May 29, 2018
Company: TherapeuticsMD, Inc.
Treatment for: Dyspareunia

Imvexxy (estradiol) is a bio-identical 17β-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

• TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause
• Imvexxy (estradiol) FDA Approval History

Consensi (amlodipine and celecoxib) Tablets

Date of Approval: May 31, 2018
Company: Purple Biotech Ltd.
Treatment for: High Blood Pressure, Osteoarthritis

Consensi (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination for the treatment of both hypertension and pain associated with osteoarthritis.

• FDA Approves Consensi (amlodipine and celecoxib) for Treatment of Hypertension and Osteoarthritis Pain
• Consensi (amlodipine and celecoxib) FDA Approval History

Olumiant (baricitinib) Tablets

Date of Approval: May 31, 2018
Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis, COVID-19, Alopecia

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.

• FDA Approves Olumiant (baricitinib) 2 mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis
• Olumiant (baricitinib) FDA Approval History

Fulphila (pegfilgrastim-jmdb) Injection

Date of Approval: June 4, 2018
Company: Mylan N.V.
Treatment for: Neutropenia Associated with Chemotherapy

Fulphila (pegfilgrastim-jmbd) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

• FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
• Fulphila (pegfilgrastim-jmdb) FDA Approval History

(moxidectin) Tablets

Date of Approval: June 13, 2018
Company: Medicines Development for Global Health
Treatment for: Onchocerciasis, River Blindness

Moxidectin is a macrocyclic lactone anthelmintic medicine indicated for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older.

• FDA Approves Moxidectin for the Treatment of River Blindness
• moxidectin FDA Approval History

Nocdurna (desmopressin acetate) Sublingual Tablets

Date of Approval: June 21, 2018
Company: Ferring Pharmaceuticals Inc.
Treatment for: Nocturia

Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults.

• Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
• Nocdurna (desmopressin acetate) FDA Approval History

Epidiolex (cannabidiol) Oral Solution

Date of Approval: June 25, 2018
Company: GW Pharmaceuticals plc
Treatment for: Seizures associated with Lennox-Gastaut Syndrome, Dravet syndrome, or Tuberous Sclerosis Complex

Epidiolex (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

• FDA Approves Epidiolex (cannabidiol) to Treat Lennox-Gastaut Syndrome and Dravet Syndrome
• Epidiolex (cannabidiol) FDA Approval History

Zemdri (plazomicin) Injection

Date of Approval: June 25, 2018
Company: Achaogen, Inc.
Treatment for: Urinary Tract Infection

Zemdri (plazomicin) is an aminoglycoside antibacterial for the treatment of complicated urinary tract infections.

• Zemdri (plazomicin) Approved by FDA for the Treatment of Adults with Complicated Urinary Tract Infections (cUTI)
• Zemdri (plazomicin) FDA Approval History

Braftovi (encorafenib) Capsules

Date of Approval: June 27, 2018
Company: Pfizer, Inc.
Treatment for: Melanoma, Metastatic, Colorectal Cancer, Non-Small Cell Lung Cancer

Braftovi (encorafenib) is a kinase inhibitor used for the treatment of melanoma, colorectal cancer, and non-small cell lung cancer.

• Array BioPharma Announces FDA Approval of Braftovi (encorafenib) in Combination with Mektovi (binimetinib) for Unresectable or Metastatic Melanoma with BRAF Mutations
• Braftovi (encorafenib) FDA Approval History

Mektovi (binimetinib) Tablets

Date of Approval: June 27, 2018
Company: Array BioPharma Inc.
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer

Mektovi (binimetinib) is a kinase inhibitor used for the treatment of melanoma and non-small cell lung cancer.

• FDA Approves Mektovi (binimetinib) and Braftovi (encorafenib) in Combination for Unresectable or Metastatic Melanoma with BRAF Mutations
• Mektovi (binimetinib) FDA Approval History

Qbrexza (glycopyrronium) Cloth for Topical Use

Date of Approval: June 28, 2018
Company: Dermira, Inc.
Treatment for: Hyperhidrosis

Qbrexza (glycopyrronium) is a topical anticholinergic contained in a single-use, pre-moistened, medicated cloth for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older.

• Dermira Receives FDA Approval for Qbrexza (glycopyrronium) Cloth to Treat Excessive Underarm Sweating
• Qbrexza (glycopyrronium) FDA Approval History

TPOXX (tecovirimat) Capsules and Injection

Date of Approval: July 13, 2018
Company: SIGA Technologies, Inc.
Treatment for: Smallpox

TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.

• FDA Approves TPOXX (tecovirimat) as the First Drug for the Treatment of Smallpox
• TPOXX (tecovirimat) FDA Approval History

Symtuza (cobicistat, darunavir, emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: July 17, 2018
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) is a once daily, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

• FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
• Symtuza (cobicistat, darunavir, emtricitabine and tenofovir alafenamide) FDA Approval History

Tibsovo (ivosidenib) Tablets

Date of Approval: July 20, 2018
Company: Servier Pharmaceuticals
Treatment for: Acute Myeloid Leukemia, Cholangiocarcinoma

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor used in the treatment of patients with IDH1-mutated acute myeloid leukemia (AML), IDH1-mutated cholangiocarcinoma, and IDH1-mutated myelodysplastic syndromes.

• FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
• Tibsovo (ivosidenib) FDA Approval History

Nivestym (filgrastim-aafi) Injection

Date of Approval: July 20, 2018
Company: Pfizer Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Febrile Neutropenia

Nivestym (filgrastim-aafi) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.

• FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
• Nivestym (filgrastim-aafi) FDA Approval History

Krintafel (tafenoquine) Tablets

Date of Approval: July 20, 2018
Company: GlaxoSmithKline
Treatment for: Malaria

Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

• FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria
• Krintafel (tafenoquine) FDA Approval History

Orilissa (elagolix) Tablets

Date of Approval: July 23, 2018
Company: AbbVie, Inc.
Treatment for: Endometriosis

Orilissa (elagolix) is an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis.

• FDA Approves Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
• Orilissa (elagolix) FDA Approval History

Perseris (risperidone) for Extended-Release Injectable Suspension

Date of Approval: July 27, 2018
Company: Indivior PLC
Treatment for: Schizophrenia

Perseris (risperidone) is a once-monthly, subcutaneous formulation of the approved atypical antipsychotic risperidone indicated for the treatment of schizophrenia in adults.

• FDA Approves Perseris (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults
• Perseris (risperidone) FDA Approval History

Azedra (iobenguane I 131) Injection

Date of Approval: July 30, 2018
Company: Progenics Pharmaceuticals Inc.
Treatment for: Pheochromocytoma; Paraganglioma

Azedra (iobenguane I 131) is a radioactive therapeutic agent for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma.

• FDA Approves Azedra (iobenguane I 131) for Rare Adrenal Tumors
• Azedra (iobenguane I 131) FDA Approval History

Mulpleta (lusutrombopag) Tablets

Date of Approval: July 31, 2018
Company: Shionogi Inc.
Treatment for: Thrombocytopenia

Mulpleta (lusutrombopag) is a once-daily, orally administered, thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical or dental procedure.

• FDA Approves Mulpleta (lusutrombopag) for Thrombocytopenia in Adults with Chronic Liver Disease
• Mulpleta (lusutrombopag) FDA Approval History

Poteligeo (mogamulizumab-kpkc) Injection

Date of Approval: August 8, 2018
Company: Kyowa Hakko Kirin Co., Ltd.
Treatment for: Mycosis Fungoides; Sézary Syndrome

Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).

• FDA Approves Poteligeo (mogamulizumab-kpkc) for Mycosis Fungoides and Sézary Syndrome
• Poteligeo (mogamulizumab-kpkc) FDA Approval History

Arakoda (tafenoquine) Tablets

Date of Approval: August 8, 2018
Company: 60 Degrees Pharmaceuticals
Treatment for: Malaria Prevention

Arakoda (tafenoquine) is an 8-aminoquinoline antimalarial drug indicated for the prophylaxis of malaria in patients aged 18 years and older.

• FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria
• Arakoda (tafenoquine) FDA Approval History

Jornay PM (methylphenidate hydrochloride) Extended-Release Capsules

Date of Approval: August 8, 2018
Company: Ironshore Pharmaceuticals & Development, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Jornay PM (methylphenidate hydrochloride) is a once-daily formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

• FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)
• Jornay PM (methylphenidate hydrochloride) FDA Approval History

Onpattro (patisiran) Injection

Date of Approval: August 10, 2018
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR)

Onpattro (patisiran) is a small interfering ribonucleic acid (siRNA) therapeutic for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR).

• FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR
• Onpattro (patisiran) FDA Approval History

Annovera (ethinyl estradiol and segesterone acetate) Vaginal System

Date of Approval: August 10, 2018
Company: The Population Council
Treatment for: Birth Control

Annovera (ethinyl estradiol and segesterone acetate) is an estrogen and progestin vaginal contraceptive system indicated to prevent pregnancy for up to a year.

• FDA Approves Annovera (segesterone acetate and ethinyl estradiol) Vaginal Contraceptive System
• Annovera (ethinyl estradiol and segesterone acetate) FDA Approval History

Galafold (migalastat) Capsules

Date of Approval: August 10, 2018
Company: Amicus Therapeutics
Treatment for: Fabry Disease

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.

• FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
• Galafold (migalastat) FDA Approval History

Cequa (cyclosporine) Ophthalmic Solution

Date of Approval: August 14, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Dry Eye Disease

Cequa (cyclosporine) ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with dry eye disease (keratoconjunctivitis sicca).

• Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
• Cequa (cyclosporine) FDA Approval History

Diacomit (stiripentol) Capsules and Powder for Oral Suspension

Date of Approval: August 20, 2018
Company: Biocodex
Treatment for: Dravet Syndrome

Diacomit (stiripentol) is an anticonvulsant for use as an adjunctive treatment with clobazam in Dravet syndrome.

• FDA Approves Diacomit (stiripentol) for Seizures Associated with Dravet Syndrome
• Diacomit (stiripentol) FDA Approval History

Oxervate (cenegermin-bkbj) Ophthalmic Solution

Date of Approval: August 22, 2018
Company: Dompé farmaceutici SpA
Treatment for: Neurotrophic Keratitis

Oxervate (cenegermin) is a recombinant human nerve growth factor (rhNGF) ophthalmic solution indicated for the treatment of neurotrophic keratitis.

• FDA Approves Oxervate (cenegermin) for Neurotrophic Keratitis
• Oxervate (cenegermin-bkbj) FDA Approval History

Inveltys (loteprednol etabonate) Ophthalmic Suspension

Date of Approval: August 22, 2018
Company: Kala Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Inveltys (loteprednol etabonate) is a nanoparticle ocular corticosteroid formulation for the treatment of post-operative ocular inflammation and pain.

• FDA Approves Inveltys (loteprednol etabonate) for Post-Operative Inflammation and Pain Following Ocular Surgery
• Inveltys (loteprednol etabonate) FDA Approval History

Takhzyro (lanadelumab-flyo) Injection

Date of Approval: August 23, 2018
Company: Shire plc
Treatment for: Hereditary Angioedema

Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) for the prevention of angioedema attacks in patients with hereditary angioedema.

• FDA Approves Takhzyro (lanadelumab-flyo) for Hereditary Angioedema
• Takhzyro (lanadelumab-flyo) FDA Approval History

Altreno (tretinoin) Lotion

Date of Approval: August 23, 2018
Company: Ortho Dermatologics
Treatment for: Acne

Altreno (tretinoin) is a topical retinoid for the treatment of acne.

• Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne
• Altreno (tretinoin) FDA Approval History

Xerava (eravacycline) Injection

Date of Approval: August 27, 2018
Company: Tetraphase Pharmaceuticals, Inc.
Treatment for: Complicated Intra-Abdominal Infections

Xerava (eravacycline) is a fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections.

• Tetraphase Pharmaceuticals Announces FDA Approval of Xerava (eravacycline) for Complicated Intra-Abdominal Infections (cIAI)
• Xerava (eravacycline) FDA Approval History

Jivi (antihemophilic factor [recombinant] PEGylated-aucl) Injection

Date of Approval: August 30, 2018
Company: Bayer HealthCare LLC
Treatment for: Hemophilia A

Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, Factor VIII concentrate indicated to treat and control bleeding in patients with hemophilia A.

• Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A
• Jivi (antihemophilic factor [recombinant] PEGylated-aucl) FDA Approval History

Pifeltro (doravirine) Tablets

Date of Approval: August 30, 2018
Company: Merck
Treatment for: HIV Infection

Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection.

• FDA Approves Merck’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients
• Pifeltro (doravirine) FDA Approval History

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: August 30, 2018
Company: Merck
Treatment for: HIV Infection

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) is a combination of a non-nucleoside reverse transcriptase inhibitor (NNRTI) and two nucleoside analogue reverse transcriptase inhibitors (NRTIs) used for the treatment of HIV-1 infection.

• FDA Approves Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Appropriate Patients
• Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) FDA Approval History

Tiglutik (riluzole) Oral Suspension

Date of Approval: September 5, 2018
Company: ITF Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Tiglutik (riluzole) is an easy-to-swallow, thickened, oral suspension formulation of the approved drug riluzole for the treatment of amyotrophic lateral sclerosis (ALS).

• ITF Pharma Announces FDA Approval of Tiglutik (riluzole) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
• Tiglutik (riluzole) FDA Approval History

Cassipa (buprenorphine and naloxone) Sublingual Film

Date of Approval: September 7, 2018
Company: Teva Pharmaceuticals USA Inc.
Treatment for: Opiate Dependence - Maintenance

Marketing Status: Discontinued

Cassipa (buprenorphine and naloxone) sublingual film is a partial‐opioid agonist and opioid antagonist combination indicated for the maintenance treatment of opioid dependence.

• FDA Approves Cassipa (buprenorphine and naloxone) Sublingual Film as Maintenance Treatment for Opioid Dependence
• Cassipa (buprenorphine and naloxone) FDA Approval History

Lumoxiti (moxetumomab pasudotox-tdfk) Injection

Date of Approval: September 13, 2018
Company: AstraZeneca and MedImmune
Treatment for: Hairy Cell Leukemia

Lumoxiti (moxetumomab pasudotox-tdfk) is an anti-CD22 recombinant immunotoxin for the treatment of adult patients with hairy cell leukemia.

• FDA Approves Lumoxiti (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia
• Lumoxiti (moxetumomab pasudotox-tdfk) FDA Approval History

Xelpros (latanoprost) Ophthalmic Emulsion

Date of Approval: September 12, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Xelpros (latanoprost) is a prostaglandin F_2α analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension.

• FDA Approves Xelpros (latanoprost ophthalmic emulsion) to Treat Open-angle Glaucoma or Ocular Hypertension
• Xelpros (latanoprost) FDA Approval History

Ajovy (fremanezumab-vfrm) Injection

Date of Approval: September 14, 2018
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Migraine Prevention

Ajovy (fremanezumab) is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand indicated for the preventive treatment of migraine.

• FDA Approves Ajovy (fremanezumab-vfrm) for Preventive Treatment of Migraine
• Ajovy (fremanezumab-vfrm) FDA Approval History

Copiktra (duvelisib) Capsules

Date of Approval: September 24, 2018
Company: Secura Bio, Inc.
Treatment for: Chronic Lymphocytic Leukemia

Copiktra (duvelisib) is a first-in-class, oral, dual phosphoinositide-3-kinase (PI3K)-delta/PI3K-gamma inhibitor for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

• FDA Approves Copiktra (duvelisib) Capsules for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
• Copiktra (duvelisib) FDA Approval History

Emgality (galcanezumab-gnlm) Injection

Date of Approval: September 27, 2018
Company: Eli Lilly and Company
Treatment for: Migraine Prevention, Cluster Headaches

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine, and for the treatment of episodic cluster headache.

• FDA Approves Emgality (galcanezumab-gnlm) for the Preventive Treatment of Migraine in Adults
• Emgality (galcanezumab-gnlm) FDA Approval History

Vizimpro (dacomitinib) Tablets

Date of Approval: September 27, 2018
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer

Vizimpro (dacomitinib) is an oral, once-daily, irreversible pan-human epidermal growth factor receptor tyrosine kinase inhibitor (TKI) indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

• FDA Approves Vizimpro (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer
• Vizimpro (dacomitinib) FDA Approval History

Libtayo (cemiplimab-rwlc) Injection

Date of Approval: September 28, 2018
Company: Sanofi
Treatment for: Squamous Cell Carcinoma, Basal Cell Carcinoma, Non-Small Cell Lung Cancer

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

• FDA Approves Libtayo (cemiplimab-rwlc) for Advanced Cutaneous Squamous Cell Carcinoma
• Libtayo (cemiplimab-rwlc) FDA Approval History

Arikayce (amikacin liposome) Inhalation Suspension

Date of Approval: September 28, 2018
Company: Insmed, Inc.
Treatment for: Mycobacterium Avium Complex (MAC) Lung Disease

Arikayce (amikacin liposome inhalation suspension) is an aminoglycoside antibacterial indicated for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options.

• FDA Approves Arikayce (amikacin liposome inhalation suspension) to treat Mycobacterium Avium Complex (MAC) Lung Disease
• Arikayce (amikacin liposome) FDA Approval History

Xyosted (testosterone enanthate) Subcutaneous Injection

Date of Approval: September 28, 2018
Company: Antares Pharma, Inc.
Treatment for: Hypogonadism, Male

Xyosted (testosterone enanthate) is a self-administered, subcutaneous injection formulation of the androgen testosterone for the treatment of male hypogonadism, also known as testosterone deficiency or Low T.

• FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
• Xyosted (testosterone enanthate) FDA Approval History

Seysara (sarecycline) Tablets

Date of Approval: October 1, 2018
Company: Almirall, S.A.
Treatment for: Acne

Seysara (sarecycline) is an oral, narrow spectrum tetracycline-derived antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

• FDA Approves Seysara (sarecycline) for the Treatment of Moderate to Severe Acne
• Seysara (sarecycline) FDA Approval History

Nuzyra (omadacycline) Tablets and Lyophilized Powder for Injection

Date of Approval: October 2, 2018
Company: Paratek Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection, Pneumonia

Nuzyra (omadacycline) is an aminomethylcycline tetracycline antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

• FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections
• Nuzyra (omadacycline) FDA Approval History

Revcovi (elapegademase-lvlr) Injection

Date of Approval: October 5, 2018
Company: Leadiant Biosciences, Inc.
Treatment for: Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID).

• FDA Approves Revcovi (elapegademase-lvlr) for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)
• Revcovi (elapegademase-lvlr) FDA Approval History

Tegsedi (inotersen) Injection

Date of Approval: October 5, 2018
Company: Ionis Pharmaceuticals, Inc.
Treatment for: Transthyretin-Related Amyloidosis

Tegsedi (inotersen) is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

• FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
• Tegsedi (inotersen) FDA Approval History

Yutiq (fluocinolone acetonide) Intravitreal Implant

Date of Approval: October 12, 2018
Company: EyePoint Pharmaceuticals, Inc.
Treatment for: Non-Infectious Posterior Segment Uveitis

Yutiq (fluocinolone acetonide) is a corticosteroid intravitreal implant indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

• FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
• Yutiq (fluocinolone acetonide) FDA Approval History

Talzenna (talazoparib) Capsules

Date of Approval: October 16, 2018
Company: Pfizer Inc.
Treatment for: Breast Cancer, Prostate Cancer

Talzenna (talazoparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of BRCA-mutated HER2-negative breast cancer and HRR gene-mutated metastatic castration-resistant prostate cancer.

• FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
• Talzenna (talazoparib) FDA Approval History

Khapzory (levoleucovorin) for Injection

Date of Approval: October 19, 2018
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Khapzory (levoleucovorin) is a folate analog indicated for:

• rescue after high-dose methotrexate therapy in patients with osteosarcoma
• diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
• treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

• Spectrum Pharmaceuticals Receives FDA Approval of Khapzory (levoleucovorin) for Injection
• Khapzory (levoleucovorin) FDA Approval History

Xofluza (baloxavir marboxil) Tablets and Granules for Oral Suspension

Date of Approval: October 24, 2018
Company: Genentech, Inc.
Treatment for: Influenza, Influenza Prophylaxis

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment and post-exposure prophylaxis of influenza in people 5 years of age and older.

• FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza
• Xofluza (baloxavir marboxil) FDA Approval History

Bijuva (estradiol and progesterone) Capsules - formerly TX-001HR

Date of Approval: October 28, 2018
Company: TherapeuticsMD, Inc.
Treatment for: Menopausal Vasomotor Symptoms

Bijuva (estradiol and progesterone) is a bio-identical hormone combination for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) due to menopause.

• FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
• Bijuva (estradiol and progesterone) FDA Approval History

Hyrimoz (adalimumab-adaz) Injection

Date of Approval: October 30, 2018
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Hyrimoz (adalimumab-adaz) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira
• Hyrimoz (adalimumab-adaz) FDA Approval History

Sympazan (clobazam) Oral Film

Date of Approval: November 1, 2018
Company: Aquestive Therapeutics, Inc.
Treatment for: Lennox-Gastaut Syndrome

Sympazan (clobazam) is an oral film benzodiazepine formulation indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

• FDA Approves Sympazan (clobazam) Oral Film for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome
• Sympazan (clobazam) FDA Approval History

Dsuvia (sufentanil) Sublingual Tablets

Date of Approval: November 2, 2018
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Dsuvia (sufentanil) is a synthetic opioid analgesic formulation for the management of acute pain that is severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.

• FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain
• Dsuvia (sufentanil) FDA Approval History

Lorbrena (lorlatinib) Tablets

Date of Approval: November 2, 2018
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer

Lorbrena (lorlatinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) positive as detected by an FDA-approved test.

• FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer
• Lorbrena (lorlatinib) FDA Approval History

Udenyca (pegfilgrastim-cbqv) Injection

Date of Approval: November 2, 2018
Company: Coherus BioSciences, Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation

Udenyca (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

• FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
• Udenyca (pegfilgrastim-cbqv) FDA Approval History

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Date of Approval: November 6, 2018
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.

• Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults
• Bryhali (halobetasol propionate) FDA Approval History

Primatene Mist (epinephrine) Inhalation Aerosol

Date of Approval: November 8, 2018
Company: Amphastar Pharmaceuticals, Inc.
Treatment for: Asthma

Primatene Mist (epinephrine) is an over-the-counter (OTC) bronchodilator used for the temporary relief of the symptoms of mild asthma. The new formulation of Primatene Mist approved November 2018 is a CFC-free metered dose inhaler (MDI) containing hydrofluoroalkane (HFA) propellants.

• FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma
• Primatene Mist (epinephrine) FDA Approval History

Yupelri (revefenacin) Inhalation Solution

Date of Approval: November 9, 2018
Company: Theravance Biopharma, Inc.
Treatment for: COPD

Yupelri (revefenacin) is a long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).

• FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
• Yupelri (revefenacin) FDA Approval History

Aemcolo (rifamycin) Delayed-Release Tablets

Date of Approval: November 16, 2018
Company: Cosmo Technologies, Ltd.
Treatment for: Traveler's Diarrhea

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.

• FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea
• Aemcolo (rifamycin) FDA Approval History

Gamifant (emapalumab-lzsg) Injection

Date of Approval: November 20, 2018
Company: Novimmune SA
Treatment for: Hemophagocytic Lymphohistiocytosis

Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH).

• FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis
• Gamifant (emapalumab-lzsg) FDA Approval History

Daurismo (glasdegib) Tablets

Date of Approval: November 21, 2018
Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Daurismo (glasdegib) is a hedgehog pathway inhibitor indicated for the combination treatment of adult patients ≥75 years with newly-diagnosed acute myeloid leukemia (AML).

• FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia
• Daurismo (glasdegib) FDA Approval History

Vitrakvi (larotrectinib) Capsules and Oral Solution

Date of Approval: November 26, 2018
Company: Loxo Oncology, Inc.
Treatment for: TRK Fusion Cancers

Vitrakvi (larotrectinib) is an oral selective tropomyosin receptor kinase (TRK) inhibitor for the treatment solid tumors harboring NTRK-fusion proteins.

• FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers
• Vitrakvi (larotrectinib) FDA Approval History

Truxima (rituximab-abbs) Injection

Date of Approval: November 28, 2018
Company: Celltrion, Inc.
Treatment for: Non-Hodgkin's Lymphoma

Truxima (rituximab-abbs) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma.

• FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan
• Truxima (rituximab-abbs) FDA Approval History

Xospata (gilteritinib) Tablets

Date of Approval: November 28, 2018
Company: Astellas Pharma Inc.
Treatment for: Acute Myeloid Leukemia

Xospata (gilteritinib) is a FLT3/AXL kinase inhibitor indicated for the treatment of patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

• FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation
• Xospata (gilteritinib) FDA Approval History

Firdapse (amifampridine phosphate) Tablets

Date of Approval: November 28, 2018
Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert-Eaton Myasthenic Syndrome

Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults and pediatric patients six years of age and older.

• FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome
• Firdapse (amifampridine phosphate) FDA Approval History

Dextenza (dexamethasone) Ophthalmic Insert

Date of Approval: November 30, 2018
Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation, Conjunctivitis, Allergic

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain, and ocular itching associated with allergic conjunctivitis.

• FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
• Dextenza (dexamethasone) FDA Approval History

Tolsura (itraconazole) Capsules

Date of Approval: December 11, 2018
Company: Mayne Pharma
Treatment for: Blastomycosis; Histoplasmosis; Aspergillosis

Tolsura (itraconazole) is an azole antifungal indicated for the treatment of certain fungal infections including blastomycosis, histoplasmosis and aspergillosis.

• FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections
• Tolsura (itraconazole) FDA Approval History

Herzuma (trastuzumab-pkrb) for Injection

Date of Approval: December 14, 2018
Company: Celltrion, Inc. and Teva Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer

Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer.

• FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
• Herzuma (trastuzumab-pkrb) FDA Approval History

Motegrity (prucalopride) Tablets

Date of Approval: December 14, 2018
Company: Shire plc
Treatment for: Chronic Idiopathic Constipation

Motegrity (prucalopride) is a selective serotonin type 4 (5‑HT4) receptor agonist for the treatment of chronic idiopathic constipation (CIC) in adults.

• FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)
• Motegrity (prucalopride) FDA Approval History

Asparlas (calaspargase pegol-mknl) Injection

Date of Approval: December 20, 2018
Company: Servier Pharmaceuticals LLC
Treatment for: Acute Lymphoblastic Leukemia

Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia.

• FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)
• Asparlas (calaspargase pegol-mknl) FDA Approval History

Ultomiris (ravulizumab-cwvz) Injection

Date of Approval: December 21, 2018
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorder

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder.

• FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
• Ultomiris (ravulizumab-cwvz) FDA Approval History

Elzonris (tagraxofusp-erzs) Injection

Date of Approval: December 21, 2018
Company: Stemline Therapeutics, Inc.
Treatment for: Blastic Plasmacytoid Dendritic Cell Neoplasm

Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

• FDA Approves Elzonris (tagraxofusp-erzs), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
• Elzonris (tagraxofusp-erzs) FDA Approval History

Inbrija (levodopa) Inhalation Powder

Date of Approval: December 21, 2018
Company: Acorda Therapeutics, Inc.
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

• FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease
• Inbrija (levodopa) FDA Approval History

ProAir Digihaler (albuterol sulfate) Inhalation Powder

Date of Approval: December 21, 2018
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Bronchospasm Prophylaxis, Asthma, COPD

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

• FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors
• ProAir Digihaler (albuterol sulfate) FDA Approval History

Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Suspension for Intramuscular Injection

Date of Approval: December 21, 2018
Company: Merck and Sanofi
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prevention, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

• FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine
• Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) FDA Approval History