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New Drug Approvals Archive for 2018

See also: New Indications and Dosage Forms 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.

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.

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.

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 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 in heavily treatment-experienced adults.

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.

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.

Tavalisse (fostamatinib) Tablets

Date of Approval: April 17, 2018
Company: Rigel Pharmaceuticals, Inc.
Treatment for: Idiopathic Thrombocytopenic Purpura

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

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).

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).

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).

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.

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.

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.

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.

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.

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.

Doptelet (avatrombopag) Tablets

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

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.

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.

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.

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.

Consensi (amlodipine and celecoxib) Tablets

Date of Approval: May 31, 2018
Company: Kitov Pharma 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.

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.

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.

(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.

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.

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.

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.

Braftovi (encorafenib) Capsules

Date of Approval: June 27, 2018
Company: Pfizer, Inc.
Treatment for: Melanoma, Metastatic, Colorectal Cancer

Braftovi (encorafenib) is a kinase inhibitor indicated:

  • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
  • in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Mektovi (binimetinib) Tablets

Date of Approval: June 27, 2018
Company: Array BioPharma Inc.
Treatment for: Melanoma, Metastatic

Mektovi (binimetinib) is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

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.

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.

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.

Tibsovo (ivosidenib) Tablets

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

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

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.

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.

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.

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.

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.

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.

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).

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.

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.

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).

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.

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.

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).

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 indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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 analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension.

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.

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).

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.

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.

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).

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.

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.

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.

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).

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).

Tegsedi (inotersen) Injection

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

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.

Talzenna (talazoparib) Capsules

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

Talzenna (talazoparib) is an oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

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.

Xofluza (baloxavir marboxil) Tablets and Granules for Oral Suspension

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

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza, and for the post-exposure prophylaxis of influenza in people 12 years of age and older.

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.

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, Maintenance, Ulcerative Colitis, Plaque Psoriasis

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

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.

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.

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.

Udenyca (pegfilgrastim-cbqv) Injection

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

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.

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.

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.

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).

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.

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

Ultomiris (ravulizumab-cwvz) Injection

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

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

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).

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.

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.

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).

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