Propecia Approval: Official FDA documents!
fda.gov/cder/foi/nda/97/0207 … ia_toc.htm
Additional documents attached:
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Approval of Finasteride drug labelling changes
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Denial by FDA of Merck’s petition for additional drug classification, targetted at pediatricians and highlighting Finasteride as producing health benefits
FDA & Merck Letters - PROSCAR labelling changes approval.pdf (219 KB)
FDA Letter - MERCK petition DENIED - List of Approved Drugs for Which Additional Pediatric Information May Produce Health Benefits.pdf (85.5 KB)