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