Original New Drug Application Approvals by US FDA (01-15 December 2021)

19 Dec 2021
Original New Drug Application Approvals by US FDA (01-15 December 2021)
New drug applications approved by US FDA as of 01-15 December 2021 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.

XACIATO
  • Active Ingredient(s): Clindamycin Phosphate
  • Strength: 2%
  • Dosage Form(s) / Route(s): Gel; Vaginal
  • Company: Dare Bioscience Inc
  • Approval Date: 07 December 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.
  • Approved Label: 07 December 2021 (PDF)
ENTADFI
  • Active Ingredient(s): Finasteride; Tadalafil
  • Strength: 5MG; 5MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Veru Inc
  • Approval Date: 09 December 2021
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.
  • Approved Label: 09 December 2021 (PDF)