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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 (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination indicated for the treatment of asthma and chronic obstructive pulmonary disease (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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