New Drug Approvals Archive - August 2016

Dysport (abobotulinumtoxinA)

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

Dysport (abobotulinumtoxinA) FDA Approval History

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.

• FDA Approves Flonase Sensimist Allergy Relief

Flonase Sensimist (fluticasone furoate) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: August 5, 2016

• FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Keytruda (pembrolizumab) FDA Approval History

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

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

Troxyca ER (naltrexone and oxycodone) FDA Approval History

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

Afluria (influenza virus vaccine) FDA Approval History

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.

• FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel

Erelzi (etanercept-szzs) FDA Approval History

Arzerra (ofatumumab)

New Indication Approved: August 30, 2016

• Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL

Arzerra (ofatumumab) FDA Approval History