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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

Zinplava (bezlotoxumab) Injection

Company: Merck & Co., Inc.
Date of Approval: October 21, 2016
Treatment for: Prevention of Clostridium Difficile Infection Recurrence

Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody designed to neutralize Clostridium difficile toxin B and prevent C. difficile infection recurrence.

Zinplava FDA Approval History

Lartruvo (olaratumab) Injection

Company: Eli Lilly and Company
Date of Approval: October 19, 2016
Treatment for: Soft Tissue Sarcoma

Lartruvo (olaratumab) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody indicated in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma.

Lartruvo FDA Approval History

Carnexiv (carbamazepine) Injection

Company: Lundbeck Inc.
Date of Approval: October 7, 2016
Treatment for: Seizures

Carnexiv (carbamazepine) is an intravenous injection formulation of the antiepileptic drug carbamazepine indicated as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible.

Carnexiv FDA Approval History

Amjevita (adalimumab-atto) Injection - formerly ABP 501

Company: Amgen Inc.
Date of Approval: September 23, 2016
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn's Disease -- Maintenance, Psoriatic Arthritis

Amjevita (adalimumab-atto) 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.

Amjevita FDA Approval History

Exondys 51 (eteplirsen) Injection

Company: Sarepta Therapeutics
Date of Approval: September 19, 2016
Treatment for: Duchenne Muscular Dystrophy

Exondys 51 (eteplirsen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

Exondys 51 FDA Approval History

Kyleena (levonorgestrel) Releasing Intrauterine System

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: September 16, 2016
Treatment for: Contraception

Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.

Kyleena FDA Approval History

Yosprala (aspirin and omeprazole) Delayed-Release Tablets

Company: Aralez Pharmaceuticals Inc.
Date of Approval: September 14, 2016
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis

Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

Yosprala FDA Approval History

Cuvitru (immune globulin subcutaneous (human)) Injection

Company: Shire US, Inc.
Date of Approval: September 13, 2016
Treatment for: Primary Immunodeficiency Syndrome

Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).

Cuvitru FDA Approval History

Lomaira (phentermine hydrochloride) Tablets

Company: KVK-Tech, Inc.
Date of Approval: September 13, 2016
Treatment for: Weight Loss, Obesity

Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.

Lomaira FDA Approval History

Erelzi (etanercept-szzs) Injection

Company: Sandoz Inc.
Date of Approval: August 30, 2016
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Erelzi (etanercept-szzs) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Erelzi FDA Approval History

Troxyca ER (naltrexone and oxycodone) Extended-Release Capsules - formerly ALO-02

Company: Pfizer Inc.
Date of Approval: August 19, 2016
Treatment for: Pain

Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) is an extended-release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Troxyca ER FDA Approval History

Sustol (granisetron) Extended-Release Injection - formerly APF530

Company: Heron Therapeutics, Inc.
Date of Approval: August 9, 2016
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Sustol (granisetron) is a long-acting 5-HT3 antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

Sustol FDA Approval History

Flonase Sensimist (fluticasone furoate) Nasal Spray

Company: GlaxoSmithKline Consumer Healthcare LP
Date of Approval: August 2, 2016
Treatment for: Allergic Rhinitis

Flonase Sensimist (fluticasone furoate) is an over-the-counter corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergies in adults and children ages 2 years and older.

Flonase Sensimist FDA Approval History

Qbrelis (lisinopril) Oral Solution

Company: Silvergate Pharmaceuticals, Inc.
Date of Approval: July 29, 2016
Treatment for: Hypertension, Congestive Heart Failure, Myocardial Infarction

Qbrelis (lisinopril) is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor lisinopril indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.

Qbrelis FDA Approval History

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) Extended-Release Tablets

Company: AbbVie Inc.
Date of Approval: July 22, 2016
Treatment for: Chronic Hepatitis C

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for the once-daily treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1 infection.

Viekira XR FDA Approval History

Syndros (dronabinol) Oral Solution

Company: Insys Therapeutics, Inc.
Date of Approval: July 1, 2016
Treatment for: Anorexia -- AIDS Patients; Nausea/Vomiting -- Chemotherapy Induced

Syndros (dronabinol) is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC) approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Syndros FDA Approval History

Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) Nasal Spray

Company: St. Renatus LLC
Date of Approval: June 29, 2016
Treatment for: Dental Anesthesia

Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) is a vasoconstrictor and local anesthetic combination administered intranasally as a topical anesthetic for use in restorative dental procedures.

Kovanaze FDA Approval History

Epclusa (sofosbuvir and velpatasvir) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: June 28, 2016
Treatment for: Chronic Hepatitis C

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Epclusa FDA Approval History
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