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

03 Jan 2024
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)