FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)

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Summary

FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) by Dr. Reddy's Laboratories, resulting in updated labeling.

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Diseases / indications

• Hyperphenylalaninemia
• Phenylketonuria

Drugs mentioned

• JAVYGTOR (Sapropterin dihydrochloride)

Snippet

SUPPL AP for JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)