Original New Drug Application Approvals by US FDA (16 - 31 January 2019)

New drug applications approved by US FDA as of 16 - 31 January 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

ONTRUZANT

• Active Ingredient(s): Trastuzumab-dttb
• Strength: 150 MG
• Dosage Form(s) / Route(s): Injectable; Injection
• Company: Samsung Bioepis Co Ltd
• Approval Date: 18 Jan 2019
• Submission Classification: Not available
• Indication(s): Indicated for:
  • The treatment of HER2-overexpressing breast cancer.
  • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
• Approved Label: 18 Jan 2019 (PDF)

TOSYMRA

• Active Ingredient(s): Sumatriptan
• Strength: 10 MG
• Dosage Form(s) / Route(s): Spray; Nasal
• Company: Dr Reddy's Labs Ltd
• Approval Date: 25 Jan 2019
• Submission Classification:  Type 3 - New Dosage Form
• Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
• Approved Label: 25 Jan 2019 (PDF)