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
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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.
- Flexion Therapeutics Announces FDA Approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis Knee Pain - October 6, 2017
- Flexion Therapeutics Announces NDA for Zilretta (FX006) Accepted by U.S. FDA - February 7, 2017
- Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain - December 12, 2016
- Flexion Therapeutics Receives Positive Guidance from FDA on NDA Submission for Zilretta for Osteoarthritis of the Knee - May 26, 2016
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.
- Novo Nordisk Receives FDA Approval for Fiasp (insulin aspart injection), a New Fast-Acting Mealtime Insulin - September 29, 2017
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.
- FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers - September 28, 2017
- FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer - July 12, 2017
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).
- FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD - September 18, 2017
- GSK Files Regulatory Submission in US for Once-Daily Closed Triple Combination Therapy FF/UMEC/VI for Patients with COPD - November 21, 2016
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.
- Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps - September 19, 2017
- OptiNose Announces FDA Acceptance for Filing of the New Drug Application for OPN-375 - January 31, 2017
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.
- Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD - September 15, 2017
- Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, for the Treatment of ADHD - November 17, 2016
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).
- FDA Approves Symbiomix Therapeutics’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women - September 18, 2017
- Symbiomix Therapeutics Announces FDA’s Acceptance of New Drug Application for Solosec with Priority Review Status - March 23, 2017
- Symbiomix Therapeutics Submits New Drug Application to US FDA for Solosec for the Treatment of BV - January 19, 2017
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).
- FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma - September 14, 2017
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.
- FDA Approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin - September 14, 2017
- Amgen and Allergan Submit Biosimilar BLA for ABP 215 to U.S. FDA - November 15, 2016
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.
- FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia - September 1, 2017
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).
- FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia - August 30, 2017
- Novartis CAR-T Cell Therapy CTL019 Unanimously (10-0) Recommended for Approval by FDA Advisory Committee to Treat Pediatric, Young Adult r/r B-Cell ALL - July 12, 2017
- Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL - April 18, 2017
- Novartis Announces First CAR-T Cell Therapy BLA for Pediatric and Young Adult Patients with r/r B-Cell ALL Granted FDA Priority Review - March 29, 2017
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).
- FDA Approves Vabomere (meropenem and vaborbactam) for Complicated Urinary Tract Infections - August 29, 2017
- The Medicines Company Announces FDA Filing Acceptance of New Drug Application for Intravenous Antibiotic Carbavance (meropenem-vaborbactam) - February 21, 2017
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.
- FDA Approves Benznidazole as First U.S. Treatment for Chagas Disease - August 29, 2017
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.
- FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira - August 29, 2017
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.
- FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients - August 24, 2017
- Adamas Announces U.S. FDA Acceptance of ADS-5102 New Drug Application for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease - January 6, 2017
- Adamas Submits New Drug Application to U.S. FDA for ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease - October 27, 2016
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.
- FDA Approves KedRAB [rabies immune globulin (Human)] for Post-Exposure Prophylaxis of Rabies Infection - August 25, 2017
- Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment - September 1, 2016
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.
- FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout - August 21, 2017
- Ironwood Announces New Drug Application for Duzallo (Fixed-Dose Combination of Lesinurad and Allopurinol) Has Been Accepted for FDA Review - January 4, 2017
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).
- FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia - August 17, 2017
- Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration - February 21, 2017
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.
- CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension - August 7, 2017
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).
- FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia - August 3, 2017
- Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status - May 31, 2017
- Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia - April 3, 2017
- Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017 - October 3, 2016
