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