Original New Drug Application Approvals by US FDA (16-31 December 2023)

New drug applications approved by US FDA as of 16-31 December 2023 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.

FILSUVEZ

• Active Ingredient(s): Birch Triterpenes
• Strength: 10%
• Dosage Form(s) / Route(s): Gel;topical
• Company: Amryt
• Approval Date: 18 December 2023
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
• Approved Label:  18 December 2023 (PDF)

WAINUA

• Active Ingredient(s): Eplontersen Sodium
• Strength: 45MG/0.8ML
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Ionis Pharma Inc
• Approval Date: 21 December 2023
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
• Approved Label:  21 December 2023 (PDF)