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New Drug Approvals Archive - August 2016

See also: New Indications and Dosage Forms for August 2016

August 2016

Flonase Sensimist (fluticasone furoate) Nasal Spray

Date of Approval: August 2, 2016
Company: GSK Consumer Healthcare
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.

Sustol (granisetron) Extended-Release Injection

Date of Approval: August 9, 2016
Company: Heron Therapeutics, Inc.
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.

Troxyca ER (naltrexone and oxycodone) Extended-Release Capsules

Date of Approval: August 19, 2016
Company: Pfizer Inc.
Treatment for: Pain

Marketing Status: Discontinued

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.

Afluria Quadrivalent (influenza virus vaccine, inactivated) Injection

Date of Approval: August 26, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis

Afluria Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in persons 6 months of age and older.

Erelzi (etanercept-szzs) Injection

Date of Approval: August 30, 2016
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Erelzi (etanercept-szzs) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Afluria Quadrivalent (influenza virus vaccine, inactivated) Injection

Date of Approval: August 26, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis

Afluria Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in persons 6 months of age and older.

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