New Drug Approvals Archive - August 2016
New Indication Approved: July 27, 2016
- Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older
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.
New Indication Approved: August 5, 2016
- FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Sustol (granisetron) Extended-Release Injection - formerly APF530
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.
- Heron Therapeutics Announces FDA Approval of Sustol (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Read more: Sustol (granisetron) FDA Approval History
Troxyca ER (naltrexone and oxycodone) Extended-Release Capsules - formerly ALO-02
Date of Approval: August 19, 2016
Company: Pfizer Inc.
Treatment for: Pain
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.
- FDA Approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Capsules with Abuse-Deterrent Properties for the Management of Pain
Afluria (influenza virus vaccine)
New Formulation Approved: August 29, 2016
- Seqirus Receives FDA Approval for Afluria Quadrivalent (Influenza Vaccine) for People 18 Years 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.
New Indication Approved: August 30, 2016
- Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL
Read more: Arzerra (ofatumumab) FDA Approval History