New Drug Approvals Archive - 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.
Read more: GoNitro (nitroglycerin) FDA Approval History
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.
- FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
Read more: Rayaldee (calcifediol) FDA Approval History
Flublok (influenza vaccine)
New Formulation Approved: June 23, 2016
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.
- FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection
New Indication Approved: June 30, 2016
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.
- St. Renatus, LLC Announces FDA Approval of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry
Epclusa (sofosbuvir and velpatasvir)
Patient Population Altered: August 1, 2017
- FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV