FDA
approval
· 2021-07-26
FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (ENDO USA, Inc.)
Summary
The FDA approved a supplemental application for sapropterin dihydrochloride, updating its approval via ENDO USA, Inc. for use in phenylketonuria.
Upgrade for the full analysis, importance score, and drug timeline.
Diseases / indications
Drugs mentioned
Snippet
SUPPL AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)