New Drug Approvals Archive - 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.

• FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
• Ontruzant (trastuzumab-dttb) FDA Approval History

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.

• FDA Approves Tosymra (sumatriptan) Nasal Spray for Acute Treatment of Migraine
• Tosymra (sumatriptan) FDA Approval History

Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 30, 2019
Company: Mylan N.V.
Treatment for: Asthma, Chronic Obstructive Pulmonary Disease

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.

• FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus
• Wixela Inhub (fluticasone propionate and salmeterol) FDA Approval History

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.

• FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares
• Gloperba (colchicine) FDA Approval History