New Drug Approvals Archive - January 2019
See also: New Indications and Dosage Forms for January 2019
January 2019
Ontruzant (trastuzumab-dttb) for Injection
Date of Approval: January 18, 2019
Company: Samsung Bioepis Co., Ltd.
Treatment for: Breast Cancer, Gastric Cancer
Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Tosymra (sumatriptan) Nasal Spray
Date of Approval: January 25, 2019
Company: Dr. Reddy's Laboratories, Inc.
Treatment for: Migraine
Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.
Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder
Date of Approval: January 30, 2019
Company: Mylan N.V.
Treatment for: Asthma, COPD
Wixela Inhub is the first approved generic version of Advair Diskus.
Gloperba (colchicine) Oral Solution
Date of Approval: January 30, 2019
Company: Romeg Therapeutics, LLC
Treatment for: Gout
Gloperba (colchicine) is an oral solution formulation of the approved drug colchicine indicated for prophylaxis of gout flares in adults.
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