Original New Drug Application Approvals by US FDA (16-31 January 2025)
04 Feb 2025
New drug applications approved by US FDA as of 16-31 January 2025 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.
BRYNOVIN
BRYNOVIN
- Active Ingredient(s): Sitagliptin Hydrochloride
- Strength: 25MG/ML
- Dosage Form(s) / Route(s): Solution;oral
- Company: Azurity
- Approval Date: 16 January 2025
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:- BRYNOVIN is not recommended in patients with type 1 diabetes.
- BRYNOVIN has not been studied in patients with a history of pancreatitis.
- Approved Label: 16 January 2025 (PDF)
- Active Ingredient(s): Datopotamab Deruxtecan-dlnk
- Strength: 100MG
- Dosage Form(s) / Route(s): Injectable; Iv (Infusion)
- Company: Daiichi Sankyo Inc
- Approval Date: 17 January 2025
- Submission Classification: NA
- Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
- Approved Label: 17 January 2025 (PDF)
- Active Ingredient(s): Suzetrigine
- Strength: 50MG
- Dosage Form(s) / Route(s): Tablet; Oral
- Company: Vertex Pharms
- Approval Date: 30 January 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of moderate to severe acute pain in adults.
- Approved Label: 30 January 2025 (PDF)