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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

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: Local 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

Tecentriq (atezolizumab) Injection

Company: Genentech, Inc.
Date of Approval: May 18, 2016
Treatment for: Bladder Cancer

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with advanced urothelial carcinoma, the most common type of bladder cancer.

Tecentriq FDA Approval History

Ameluz (aminolevulinic acid) Gel - formerly BF-200 ALA

Company: Biofrontera AG
Date of Approval: May 10, 2016
Treatment for: Actinic Keratosis

Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.

Ameluz FDA Approval History

Nuplazid (pimavanserin) Tablets

Company: Acadia Pharmaceuticals Inc.
Date of Approval: April 29, 2016
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

Nuplazid FDA Approval History

Akovaz (ephedrine sulfate) Injection

Company: Flamel Technologies
Date of Approval: April 29, 2016
Treatment for: Hypotension

Akovaz (ephedrine sulfate) is a pressor agent administered parenterally to address clinically important hypotension in surgical settings.

Akovaz FDA Approval History
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