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New Drug Approvals Archive - June 2016

June 2016

Netspot (gallium Ga 68 dotatate) Injection

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

Juvederm (dermal filler)

New Formulation Approved: June 1, 2016
Treatment for: Facial Rejuvenation

Byvalson (nebivolol and valsartan) Tablets

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

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

Date of Approval: June 10, 2016
Company: PaxVax Bermuda Ltd.
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.

GoNitro (nitroglycerin) Sublingual Powder

Date of Approval: June 8, 2016
Company: Espero Pharmaceuticals, Inc.
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.

Rayaldee (calcifediol) Extended Release Capsules

Date of Approval: June 17, 2016
Company: OPKO Health, Inc.
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.

Epclusa (sofosbuvir and velpatasvir) Tablets

Date of Approval: June 28, 2016
Company: Gilead Sciences, Inc.
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.

Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) Nasal Spray

Date of Approval: June 29, 2016
Company: St. Renatus, LLC
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.

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