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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Zilretta (triamcinolone acetonide) Sustained-Release Intra-Articular Injection

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

Zilretta FDA Approval History

Fiasp (insulin aspart) Injection

Company: Novo Nordisk
Date of Approval: September 29, 2017
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 with diabetes mellitus. Fiasp is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption.

Fiasp FDA Approval History

Verzenio (abemaciclib) Tablets

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

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 for the treatment of metastatic breast cancer.

Verzenio FDA Approval History

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

Company: GlaxoSmithKline
Date of Approval: September 18, 2017
Treatment for: Chronic Obstructive Pulmonary Disease

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

Trelegy Ellipta FDA Approval History

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

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

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

Xhance FDA Approval History

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

Company: Neos Therapeutics, Inc.
Date of Approval: September 15, 2017
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.

Adzenys ER FDA Approval History

Solosec (secnidazole) Oral Granules

Company: Symbiomix Therapeutics, LLC
Date of Approval: September 15, 2017
Treatment for: Bacterial Vaginosis

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

Solosec FDA Approval History

Aliqopa (copanlisib) Injection

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: September 14, 2017
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).

Aliqopa FDA Approval History

Mvasi (bevacizumab-awwb) Injection - formerly ABP 215

Company: Amgen Inc.
Date of Approval: September 14, 2017
Treatment for: Non-Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical 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, and cervical cancer.

Mvasi FDA Approval History

Mylotarg (gemtuzumab ozogamicin) Injection

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

Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.

Mylotarg FDA Approval History

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion - formerly CTL019

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

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for use in pediatric and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL).

Kymriah FDA Approval History

Vabomere (meropenem and vaborbactam) Injection - formerly Carbavance

Company: The Medicines Company
Date of Approval: August 29, 2017
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).

Vabomere FDA Approval History

benznidazole Tablets

Company: Chemo Research, S. L.
Date of Approval: August 29, 2017
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.

benznidazole FDA Approval History

Cyltezo (adalimumab-adbm) Injection

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: August 25, 2017
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, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Cyltezo FDA Approval History

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

Company: Adamas Pharmaceuticals, Inc.
Date of Approval: August 24, 2017
Treatment for: Levodopa-Induced Dyskinesia

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

Gocovri FDA Approval History

KedRAB (rabies immunoglobulin human) Injection

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

KedRAB FDA Approval History

Duzallo (allopurinol and lesinurad) Tablets

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

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.

Duzallo FDA Approval History

Besponsa (inotuzumab ozogamicin) for Injection

Company: Pfizer Inc.
Date of Approval: August 17, 2017
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).

Besponsa FDA Approval History

CaroSpir (spironolactone) Oral Suspension

Company: CMP Pharma, Inc.
Date of Approval: August 4, 2017
Treatment for: Congestive Heart Failure, Edema, Hypertension

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.

CaroSpir FDA Approval History

Vyxeos (cytarabine and daunorubicin) Injection

Company: Jazz Pharmaceuticals plc
Date of Approval: August 3, 2017
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 adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Vyxeos FDA Approval History
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