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

• FDA Approves Netspot (gallium Ga 68 dotatate) Imaging Agent to Detect Rare Neuroendocrine Tumors

Netspot (gallium Ga 68 dotatate) FDA Approval History

Juvederm (dermal filler)

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

• FDA Approves Juvéderm Volbella XC for Use in Lips and Perioral Rhytids

Juvederm (dermal filler) FDA Approval History

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.

• Allergan Announces FDA Approval of Byvalson (nebivolol and valsartan) for Hypertension

Byvalson (nebivolol and valsartan) FDA Approval History

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.

• FDA Approves Vaxchora (Cholera Vaccine, Live, Oral) to Prevent Cholera in Travelers

Vaxchora (cholera vaccine, live, oral) FDA Approval History

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.

• Espero Pharmaceuticals Receives FDA Approval for GoNitro (nitroglycerin) Sublingual Powder

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

Rayaldee (calcifediol) FDA Approval History

Flublok (influenza vaccine)

New Formulation Approved: June 23, 2016

• FDA Approved Longer Shelf Life for the Game Changer, Flublok Influenza Vaccine

Flublok (influenza vaccine) FDA Approval History

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

Epclusa (sofosbuvir and velpatasvir) FDA Approval History

Humira (adalimumab)

New Indication Approved: June 30, 2016

• AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis

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

Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) FDA Approval History