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FDA approval · 2021-07-26

FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (ENDO USA, Inc.)

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Summary

The FDA approved a supplemental application for sapropterin dihydrochloride, updating its approval via ENDO USA, Inc. for use in phenylketonuria.

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Diseases / indications

Drugs mentioned

  • Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

SUPPL AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)