REGULATORY ACTIVITY

Overview • US FDA • Health Canada • European Medicines Agency (EMA) • France • Germany • Sweden • United Kingdom • Australia • Japan • Korea • Document library • Posts

Regulatory document library

Propecia (finasteride 1 mg)

• Approval package – 1997
• Dermatologic and Ophthalmic Drugs Advisory Committee Meeting No. 48 regarding Propecia, sponsored by Merck. November 13, 1997. Archived
• Label – Jan 2014
• Label – Jun 2021

See also: history of changes to adverse effects on the Propecia label

Proscar (finasteride 5 mg)

• Approval documents – 1990s
  • Approval package
  • Administrative documents
  • Approval letter
  • Biopharmaceutics review
  • Correspondence
• Oncologic Drugs Advisory Committee Meeting re: efficacy and safety of Proscar and Avodart for reducing the risk of prostate cancer on December 1, 2010. Archived
• Label – Jul 2003
• Label – Jun 2021

See also: How to access clinical trial data from RIAT Initiative (Restoring Invisible & Abandoned Trials).