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FDA approval · 2013-11-22

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

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Summary

FDA approved a supplemental application for KUVAN (sapropterin dihydrochloride) submitted by BioMarin, resulting in an updated labeling for the drug. The supple…

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Diseases / indications

Drugs mentioned

  • KUVAN (Sapropterin dihydrochloride)

Snippet

SUPPL AP for KUVAN (SAPROPTERIN DIHYDROCHLORIDE)