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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

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: GSK Consumer Healthcare
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

Rayaldee (calcifediol) Extended Release Capsules

Company: OPKO Health, Inc.
Date of Approval: June 17, 2016
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease.

Rayaldee FDA Approval History

Vaxchora (cholera vaccine, live, oral) Suspension for Oral Administration

Company: PaxVax Bermuda Ltd.
Date of Approval: June 10, 2016
Treatment for: Cholera Prophylaxis

Vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas.

Vaxchora FDA Approval History

GoNitro (nitroglycerin) Sublingual Powder

Company: Espero Pharmaceuticals, Inc.
Date of Approval: June 8, 2016
Treatment for: Angina Pectoris Prophylaxis

GoNitro (nitroglycerin) is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

GoNitro FDA Approval History

Byvalson (nebivolol and valsartan) Tablets

Company: Forest Laboratories, Inc.
Date of Approval: June 3, 2016
Treatment for: Hypertension

Byvalson (nebivolol and valsartan) is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) fixed dose combination indicated for the treatment of hypertension.

Byvalson FDA Approval History

Netspot (gallium Ga 68 dotatate) Injection

Company: Advanced Accelerator Applications USA, Inc.
Date of Approval: June 1, 2016
Treatment for: Diagnostic

Netspot (gallium Ga 68 dotatate) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors

Netspot FDA Approval History

Zinbryta (daclizumab) Injection

Company: AbbVie, Inc. and Biogen
Date of Approval: May 27, 2016
Treatment for: Multiple Sclerosis

Zinbryta (daclizumab) is an interleukin-2 receptor blocking antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Zinbryta FDA Approval History

Axumin (fluciclovine F 18) Injection

Company: Blue Earth Diagnostics, Ltd.
Date of Approval: May 27, 2016
Treatment for: Diagnostic

Axumin (fluciclovine F 18) a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected recurrent prostate cancer.

Axumin FDA Approval History

Afstyla (antihemophilic factor (recombinant), single chain) for Injection

Company: CSL Behring
Date of Approval: May 25, 2016
Treatment for: Hemophilia A

Afstyla (antihemophilic factor (recombinant), single chain, is a recombinant, antihemophilic factor indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

Afstyla FDA Approval History
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