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New Drug Approvals Archive for 2017

See also: New Indications and Dosage Forms for 2017

Bydureon BCise (exenatide) Extended-Release Injectable Suspension

Date of Approval: October 20, 2017
Company: AstraZeneca
Treatment for: Diabetes, Type 2

Bydureon BCise (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients with type 2 diabetes.

Arymo ER (morphine sulfate) Extended-Release Tablets

Date of Approval: January 9, 2017
Company: Egalet Corporation
Treatment for: Pain

Marketing Status: Discontinued

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation for the management of severe pain.

Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

Date of Approval: January 17, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Pain

Marketing Status: Discontinued

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Trulance (plecanatide) Tablets

Date of Approval: January 19, 2017
Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation, Chronic, Irritable Bowel Syndrome

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

Rhofade (oxymetazoline hydrochloride) Cream

Date of Approval: January 18, 2017
Company: Allergan plc
Treatment for: Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

AirDuo RespiClick (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

ArmonAir RespiClick (fluticasone propionate) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

Parsabiv (etelcalcetide) Injection

Date of Approval: February 7, 2017
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Emflaza (deflazacort) Tablets and Oral Suspension

Date of Approval: February 9, 2017
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Emflaza (deflazacort) is a glucocorticoid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Siliq (brodalumab) Injection

Date of Approval: February 15, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis

Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis.

Qtern (dapagliflozin and saxagliptin) Tablets

Date of Approval: February 27, 2017
Company: AstraZeneca
Treatment for: Diabetes, Type 2

Qtern (dapagliflozin and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

Xermelo (telotristat ethyl) Tablets

Date of Approval: February 28, 2017
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome Diarrhea

Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.

Odactra (house dust mite allergen extract) Sublingual Tablets

Date of Approval: March 1, 2017
Company: ALK-Abelló A/S
Treatment for: House Dust Mite Allergies

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

Noctiva (desmopressin acetate) Nasal Spray

Date of Approval: March 3, 2017
Company: Serenity Pharmaceuticals, LLC
Treatment for: Nocturia

Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.

Kisqali (ribociclib) Tablets - formerly LEE011

Date of Approval: March 13, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 indicated for the combination treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- metastatic breast cancer.

Xadago (safinamide) Tablets

Date of Approval: March 21, 2017
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Bavencio (avelumab) Injection

Date of Approval: March 23, 2017
Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma, Urothelial Carcinoma, Renal Cell Carcinoma

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

Symproic (naldemedine) Tablets

Date of Approval: March 23, 2017
Company: Shionogi Inc.
Treatment for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

Zejula (niraparib) Capsules

Date of Approval: March 27, 2017
Company: GSK
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the treatment of patients with ovarian, fallopian tube, or primary peritoneal cancer.

Dupixent (dupilumab) Injection

Date of Approval: March 28, 2017
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis, Asthma, Chronic Rhinosinusitis with Nasal Polyps, Eosinophilic Esophagitis

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and eosinophilic esophagitis.

Ocrevus (ocrelizumab) Injection

Date of Approval: March 28, 2017
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

Austedo (deutetrabenazine) Tablets - formerly SD-809

Date of Approval: April 3, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington's Disease, Tardive Dyskinesia

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia.

Ingrezza (valbenazine) Capsules

Date of Approval: April 11, 2017
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia

Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor for the treatment of tardive dyskinesia.

Renflexis (infliximab-abda) Injection

Date of Approval: April 21, 2017
Company: Samsung Bioepis Co., Ltd.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

RoxyBond (oxycodone hydrochloride) Tablets

Date of Approval: April 20, 2017
Company: Protega Pharmaceuticals LLC
Treatment for: Pain

RoxyBond (oxycodone hydrochloride) is an immediate-release, abuse-deterrent, narcotic analgesic formulation for the management of severe pain.

Xatmep (methotrexate) Oral Solution

Date of Approval: April 25, 2017
Company: Silvergate Pharmaceuticals, Inc.
Treatment for: Acute Lymphoblastic Leukemia, Juvenile Idiopathic Arthritis

Xatmep (methotrexate) is a folate analog metabolic inhibitor in an oral solution formulation indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and for the management of pediatric patients with active polyarticular juvenile idiopathic arthritis.

Brineura (cerliponase alfa) Injection

Date of Approval: April 27, 2017
Company: BioMarin Pharmaceutical Inc.
Treatment for: CLN2 Disease

Brineura (cerliponase alfa) is an enzyme replacement therapy for the restoration of tripeptidyl peptidase-1 (TPP1) enzyme activity in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), or TPP1 deficiency, a form of Batten disease.

Rydapt (midostaurin) Capsules - formerly PKC412

Date of Approval: April 28, 2017
Company: Novartis
Treatment for: Acute Myeloid Leukemia, Systemic Mastocytosis

Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.

Tymlos (abaloparatide) Injection

Date of Approval: April 28, 2017
Company: Radius Health, Inc.
Treatment for: Osteoporosis

Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis.

Alunbrig (brigatinib) Tablets

Date of Approval: April 28, 2017
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non-Small Cell Lung Cancer

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Imfinzi (durvalumab) Injection

Date of Approval: May 1, 2017
Company: AstraZeneca
Treatment for: Non-Small Cell Lung Cancer, Small Cell Lung Cancer

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

  • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
  • in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Radicava (edaravone) Injection

Date of Approval: May 5, 2017
Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Radicava (edaravone) is a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.

Kevzara (sarilumab) Injection

Date of Approval: May 22, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis

Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection

Date of Approval: May 31, 2017
Company: Novo Nordisk
Treatment for: Hemophilia B

Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B.

Zerviate (cetirizine hydrochloride) Ophthalmic Solution

Date of Approval: May 30, 2017
Company: Nicox S.A.
Treatment for: Conjunctivitis, Allergic

Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.

Gleolan (aminolevulinic acid hydrochloride) Oral Solution

Date of Approval: June 6, 2017
Company: NX Development Corp.
Treatment for: Optical Imaging During Glioma Surgery

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent indicated for use in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.

Symjepi (epinephrine) Injection

Date of Approval: June 15, 2017
Company: Adamis Pharmaceuticals Corporation
Treatment for: Allergic Reactions

Symjepi (epinephrine) is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis.

Baxdela (delafloxacin) Tablets and Injection

Date of Approval: June 19, 2017
Company: Melinta Therapeutics
Treatment for: Skin and Structure Infection, Pneumonia

Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.

Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets

Date of Approval: June 19, 2017
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Mydayis (amphetamine mixed salts)

Date of Approval: June 20, 2017
Company: Shire plc
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Mydayis (amphetamine mixed salts) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

Rituxan Hycela (rituximab and hyaluronidase human) Injection

Date of Approval: June 22, 2017
Company: Genentech, Inc.
Treatment for: Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia

Rituxan Hycela (rituximab and hyaluronidase human) is a subcutaneous monoclonal antibody and hyaluronidase human formulation for the treatment of adult patients with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).

Haegarda (C1 esterase inhibitor (human)) Subcutaneous Injection - formerly CSL830

Date of Approval: June 22, 2017
Company: CSL Behring
Treatment for: Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

Bevyxxa (betrixaban) Capsules

Date of Approval: June 23, 2017
Company: Portola Pharmaceuticals Inc.
Treatment for: Prevention of Venous Thromboembolism

Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized for an acute medical illness.

Triptodur (triptorelin) Injection

Date of Approval: June 29, 2017
Company: Arbor Pharmaceuticals, LLC
Treatment for: Precocious Puberty

Triptodur (triptorelin) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty.

Endari (L-glutamine) Oral Powder

Date of Approval: July 7, 2017
Company: Emmaus Life Sciences Inc.
Treatment for: Anemia, Sickle Cell

Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.

Tremfya (guselkumab) Injection

Date of Approval: July 13, 2017
Company: Janssen Biotech, Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis

Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis in adults.

Nerlynx (neratinib) Tablets

Date of Approval: July 17, 2017
Company: Puma Biotechnology, Inc.
Treatment for: Breast Cancer

Nerlynx (neratinib) is a tyrosine kinase inhibitor indicated:

  • as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
  • in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Tablets

Date of Approval: July 18, 2017
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis C

Vosevi (sofosbuvir, velpatasvir and voxilaprevir or SOF/VEL/VOX) is a fixed-dose combination of a nucleotide analog NS5B polymerase inhibitor (SOF), a pangenotypic NS5A inhibitor (VEL), and a pangenotypic NS3/4A protease inhibitor (VOX) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.

Idhifa (enasidenib) Tablets

Date of Approval: August 1, 2017
Company: Celgene Corporation
Treatment for: Acute Myeloid Leukemia

Idhifa (enasidenib) is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

Vyxeos (cytarabine and daunorubicin) Injection

Date of Approval: August 3, 2017
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia

Vyxeos (cytarabine and daunorubicin liposome injection) is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor, and daunorubicin, an anthracycline topoisomerase inhibitor, indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Mavyret (glecaprevir and pibrentasvir) Tablets and Oral Pellets

Date of Approval: August 3, 2017
Company: AbbVie Inc.
Treatment for: Hepatitis C

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

CaroSpir (spironolactone) Oral Suspension

Date of Approval: August 4, 2017
Company: CMP Pharma, Inc.
Treatment for: Heart Failure, Edema, High Blood Pressure

CaroSpir (spironolactone) is an oral suspension formulation of the potassium-sparing diuretic spironolactone indicated for the treatment of heart failure, management of edema, and for use as an add-on therapy in the treatment of hypertension.

Besponsa (inotuzumab ozogamicin) for Injection

Date of Approval: August 17, 2017
Company: Pfizer Inc.
Treatment for: Acute Lymphoblastic Leukemia

Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Duzallo (allopurinol and lesinurad) Tablets

Date of Approval: August 18, 2017
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Gout

Marketing Status: Discontinued

Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for the treatment of hyperuricemia in patients with uncontrolled gout.

Gocovri (amantadine hydrochloride) Extended-Release Capsules - formerly ADS-5102

Date of Approval: August 24, 2017
Company: Adamas Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy indicated:
  • for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
  • as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

KedRAB (rabies immunoglobulin human) Injection

Date of Approval: August 23, 2017
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies Prophylaxis

KedRAB [rabies immunoglobulin (human)] is a human plasma derived anti-rabies immunoglobulin indicated for post-exposure prophylaxis (PEP) of rabies infection.

Cyltezo (adalimumab-adbm) Injection

Date of Approval: August 25, 2017
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Acute, Crohn's Disease, Maintenance, Ulcerative Colitis, Plaque Psoriasis

Cyltezo (adalimumab-adbm) 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.

(benznidazole) Tablets

Date of Approval: August 29, 2017
Company: Chemo Research, S. L.
Treatment for: Chagas Disease

Benznidazole is an antiprotozoal indicated for the treatment of Chagas disease, or American trypanosomiasis, a parasitic infection caused by Trypanosoma cruzi.

Vabomere (meropenem and vaborbactam) Injection - formerly Carbavance

Date of Approval: August 29, 2017
Company: The Medicines Company
Treatment for: Urinary Tract Infection

Vabomere (meropenem and vaborbactam) is a carbapenem and beta-lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion - formerly CTL019

Date of Approval: August 30, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia, B Cell Lymphoma, Follicular Lymphoma

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of B-cell acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma (FL).

Mylotarg (gemtuzumab ozogamicin) Injection

Date of Approval: September 1, 2017
Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for:

  • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.
  • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.

Aliqopa (copanlisib) Injection

Date of Approval: September 14, 2017
Company: Bayer Healthcare Pharmaceuticals, Inc.
Treatment for: Follicular Lymphoma

Aliqopa (copanlisib) is a phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL).

Mvasi (bevacizumab-awwb) Injection

Date of Approval: September 14, 2017
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Mvasi (bevacizumab-awwb) is an anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Adzenys ER (amphetamine) Extended-Release Liquid Suspension - formerly NT-0201

Date of Approval: September 15, 2017
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)

Adzenys ER (amphetamine) is an extended-release liquid suspension formulation of the central nervous system (CNS) stimulant amphetamine indicated for the treatment of ADHD in patients 6 years and older.

Solosec (secnidazole) Oral Granules

Date of Approval: September 15, 2017
Company: Lupin Pharmaceuticals, Inc.
Treatment for: Bacterial Vaginosis, Trichomoniasis

Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV) and trichomoniasis.

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta2-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

Xhance (fluticasone propionate) Nasal Spray - formerly OPN-375

Date of Approval: September 18, 2017
Company: OptiNose US Inc.
Treatment for: Nasal Polyps

Xhance (fluticasone propionate) is a topical nasal corticosteroid indicated for the treatment of nasal polyps.

Verzenio (abemaciclib) Tablets

Date of Approval: September 28, 2017
Company: Eli Lilly and Company
Treatment for: Breast Cancer

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 used for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+ HER2-) metastatic breast cancer.

Fiasp (insulin aspart) Injection

Date of Approval: September 29, 2017
Company: Novo Nordisk
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Fiasp (insulin aspart) is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Fiasp is a newer formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of initial insulin absorption.

Ascor (ascorbic acid) Injection

Date of Approval: October 2, 2017
Company: McGuff Pharmaceuticals, Inc.
Treatment for: Scurvy

Ascor (ascorbic acid) is an intravenous vitamin C formulation indicated for the short term treatment of scurvy.

Zilretta (triamcinolone acetonide) Extended-Release Injectable Suspension

Date of Approval: October 6, 2017
Company: Flexion Therapeutics, Inc.
Treatment for: Osteoarthritis

Zilretta (triamcinolone acetonide extended-release injectable suspension) is a corticosteroid intra-articular injection indicated for the management of osteoarthritis pain of the knee.

Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion - formerly KTE-C19

Date of Approval: October 18, 2017
Company: Kite Pharma, Inc.
Treatment for: Large B-Cell Lymphoma; Follicular Lymphoma

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) used for the treatment of large B-cell lymphoma and follicular lymphoma.

Shingrix (zoster vaccine recombinant, adjuvanted) Injection

Date of Approval: October 20, 2017
Company: GlaxoSmithKline
Treatment for: Herpes Zoster, Prophylaxis

Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

Calquence (acalabrutinib) Capsules and Tablets

Date of Approval: October 31, 2017
Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.

Vyzulta (latanoprostene bunod) Ophthalmic Solution - formerly Vesneo

Date of Approval: November 2, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Vyzulta (latanoprostene bunod) is a nitric oxide donating prostaglandin receptor agonist for the treatment of patients with open angle glaucoma or ocular hypertension.

Prevymis (letermovir) Tablets and Injection

Date of Approval: November 8, 2017
Company: Merck & Co., Inc.
Treatment for: CMV Prophylaxis

Prevymis (letermovir) is a CMV DNA terminase complex inhibitor indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult allogeneic hematopoietic stem cell transplant patients.

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) Injection

Date of Approval: November 10, 2017
Company: Dynavax Technologies Corporation
Treatment for: Hepatitis B Prevention

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) is a vaccine for use in the immunization against infection caused by all known subtypes of hepatitis B virus.

Cinvanti (aprepitant) Injection

Date of Approval: November 9, 2017
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Abilify MyCite (aripiprazole) Tablets with Sensor

Date of Approval: November 13, 2017
Company: Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health
Treatment for: Schizophrenia, Bipolar Disorder, Depression

Abilify MyCite (aripiprazole) is a tablet formulation of the approved atypical antipsychotic aripiprazole embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

Fasenra (benralizumab) Injection

Date of Approval: November 14, 2017
Company: AstraZeneca
Treatment for: Asthma

Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody indicated for the treatment of patients with severe eosinophilic asthma.

Mepsevii (vestronidase alfa) Injection

Date of Approval: November 15, 2017
Company: Ultragenyx Pharmaceutical, Inc.
Treatment for: Mucopolysaccharidosis Type VII

Mepsevii (vestronidase alfa) is a recombinant human lysosomal beta glucuronidase indicated for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

Hemlibra (emicizumab-kxwh) Injection

Date of Approval: November 16, 2017
Company: Genentech, Inc.
Treatment for: Hemophilia A with Inhibitors, Hemophilia A

Hemlibra (emicizumab-kxwh) is a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Juluca (dolutegravir and rilpivirine) Tablets

Date of Approval: November 21, 2017
Company: ViiV Healthcare
Treatment for: HIV Infection

Juluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of virologically suppressed HIV-1 infection.

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution

Date of Approval: November 28, 2017
Company: Ferring Pharmaceuticals Inc.
Treatment for: Bowel Preparation

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy.

Sublocade (buprenorphine) Sustained-Release Injection - formerly RBP-6000

Date of Approval: November 30, 2017
Company: Indivior PLC
Treatment for: Opioid Use Disorder

Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).

Impoyz (clobetasol propionate) Cream

Date of Approval: November 28, 2017
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Plaque Psoriasis

Impoyz (clobetasol propionate) is a high potency topical corticosteroid indicated for the treatment of moderate to severe plaque psoriasis.

Ogivri (trastuzumab-dkst) for Injection

Date of Approval: December 1, 2017
Company: Mylan GmbH
Treatment for: Breast Cancer, Gastric Cancer

Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.

Lonhala Magnair (glycopyrrolate) Inhalation Solution

Date of Approval: December 5, 2017
Company: Sunovion Pharmaceuticals Inc.
Treatment for: COPD

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Ozempic (semaglutide) Injection

Date of Approval: December 5, 2017
Company: Novo Nordisk
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog for the treatment type 2 diabetes, and to reduce the risk of major cardiovascular events in patients with type 2 diabetes and known heart disease.

Admelog (insulin lispro) Injection

Date of Approval: December 11, 2017
Company: Sanofi
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Admelog (insulin lispro) is a follow-on rapid-acting human insulin analog (referenced to Humalog) for the treatment of patients with type 1 and type 2 diabetes.

Sinuva (mometasone furoate) Sinus Implant

Date of Approval: December 8, 2017
Company: Intersect ENT, Inc.
Treatment for: Nasal Polyps

Sinuva (mometasone furoate) is a corticosteroid-eluting sinus implant indicated for the treatment of recurrent nasal polyp disease.

Ixifi (infliximab-qbtx) Injection

Date of Approval: December 13, 2017
Company: Pfizer Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Ixifi (infliximab-qbtx) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Xepi (ozenoxacin) Cream

Date of Approval: December 11, 2017
Company: Medimetriks Pharmaceuticals, Inc.
Treatment for: Impetigo

Xepi (ozenoxacin) is a topical non-fluorinated quinolone for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

Eskata (hydrogen peroxide) Topical Solution

Date of Approval: December 14, 2017
Company: Aclaris Therapeutics, Inc.
Treatment for: Seborrheic Keratoses

Eskata (hydrogen peroxide) 40% (w/w) topical solution is a high-concentration hydrogen peroxide formulation for the treatment of raised seborrheic keratoses.

Prexxartan (valsartan) Oral Solution

Date of Approval: December 19, 2017
Company: Medicure Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Marketing Status: Discontinued

Prexxartan (valsartan) is an angiotensin II receptor blocker (ARB) oral solution formulation indicated for the treatment of hypertension, heart failure, and left ventricular dysfunction following myocardial infarction.

Rhopressa (netarsudil) Ophthalmic Solution

Date of Approval: December 18, 2017
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma

Rhopressa (netarsudil ophthalmic solution) is a Rho kinase inhibitor for the treatment of open-angle glaucoma or ocular hypertension.

Luxturna (voretigene neparvovec) Intraocular Suspension for Subretinal Injection

Date of Approval: December 19, 2017
Company: Spark Therapeutics
Treatment for: Biallelic RPE65-Mediated Inherited Retinal Disease

Luxturna (voretigene neparvovec) is an adeno-associated viral (AAV) vector gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).

Macrilen (macimorelin) for Oral Solution

Date of Approval: December 20, 2017
Company: Aeterna Zentaris Inc.
Treatment for: Diagnosis of Adult Growth Hormone Deficiency

Macrilen (macimorelin) is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.

Giapreza (angiotensin II) Injection - formerly LJPC-501

Date of Approval: December 21, 2017
Company: La Jolla Pharmaceutical Company
Treatment for: Hypotension, Shock

Giapreza (angiotensin II) is a synthetic human angiotensin II vasoconstrictor indicated for the treatment of hypotension in adults with septic or other distributive shock.

Steglatro (ertugliflozin) Tablets

Date of Approval: December 19, 2017
Company: Merck
Treatment for: Diabetes, Type 2

Steglatro (ertugliflozin) is a sodium-glucose co-transporter-2 (SGLT2) inhibitor used to help improve glycemic control in adults with type 2 diabetes.

Steglujan (ertugliflozin and sitagliptin) Tablets

Date of Approval: December 19, 2017
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2

Steglujan (ertugliflozin and sitagliptin) is a sodium glucose co-transporter 2 (SGLT2) inhibitor, and dipeptidyl peptidase-4 (DPP-4) inhibitor combination used to improve glycemic control in adults with type 2 diabetes.

Segluromet (ertugliflozin and metformin hydrochloride) Tablets

Date of Approval: December 19, 2017
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2

Segluromet (ertugliflozin and metformin hydrochloride) is a sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination used to improve glycemic control in adults with type 2 diabetes.

Lumify (brimonidine tartrate) Ophthalmic Solution

Date of Approval: December 22, 2017
Company: Bausch + Lomb
Treatment for: Ocular Redness

Lumify (brimonidine tartrate) is an over-the-counter (OTC) formulation of the alpha-adrenergic agonist brimonidine indicated for use in the treatment of ocular redness.

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta2-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

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