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FDA approval · 2025-09-03

FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (TRUPHARMA, LLC)

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Summary

FDA approved the original application for sapropterin dihydrochloride from Trupharma, LLC, for the treatment of phenylketonuria by reducing phenylalanine levels…

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Diseases / indications

Drugs mentioned

  • Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)