Original New Drug Application Approvals by US FDA (01 - 15 September 2019)
17 Sep 2019
New drug application approved by US FDA as of 01 - 15 September 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.
- Active Ingredient(s): Glucagon
- Strength: 0.5 mg; 1 mg
- Dosage Form(s) / Route(s): Injectable; injection
- Company: Xeris Pharma, Inc.
- Approval Date: 10 September 2019
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
- Approved Label: 10 September 2019 (PDF)
- Active Ingredient(s): Tenapanor
- Strength: 50 mg
- Dosage Form(s) / Route(s): Tablet; oral
- Company: Ardelyx, Inc.
- Approval Date: 12 September 2019
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
- Approved Label: 12 September 2019 (PDF)