FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

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Summary

The FDA approved BioMarin's supplemental application for KUVAN (sapropterin dihydrochloride), resulting in an approved update to its labeling and indications.

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Diseases / indications

• Hyperphenylalaninemia
• Phenylketonuria
• Tetrahydrobiopterin Deficiency

Drugs mentioned

• KUVAN (Sapropterin dihydrochloride)

Snippet

SUPPL AP for KUVAN (SAPROPTERIN DIHYDROCHLORIDE)