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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.

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.

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