Original New Drug Application Approvals by US FDA (01 - 15 March 2022)

16 Mar 2022
Original New Drug Application Approvals by US FDA (01 - 15 March 2022)
New drug applications approved by US FDA as of 01-15 March 2022 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.

ADLARITY
  • Active Ingredient(s): Donepezil Hydrochloride
  • Strength: 5MG/24HR; 10MG/24HR
  • Dosage Form(s) / Route(s): System; Transdermal
  • Company: Corium, Inc.
  • Approval Date: 11 March 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.
  • Approved Label: 11 March 2022 (PDF)