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

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Summary

The FDA approved a supplemental application for sapropterin dihydrochloride from Endo USA, Inc., indicating an update to the product’s labeling. This action may…

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Diseases / indications

• Hyperphenylalaninemia
• Phenylketonuria

Drugs mentioned

• Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

SUPPL AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)