REGULATORY ACTIVITY
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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
- 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).