FDA
approval
· 2015-03-09
FDA Approved: EDEX — Supplemental Application (Endo USA, Inc.)
Summary
The FDA approved a supplemental application for EDEX (alprostadil) from Endo USA, Inc., indicating changes to the product’s labeling under NDA 020649.
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Diseases / indications
Drugs mentioned
Snippet
SUPPL AP for EDEX (ALPROSTADIL)