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

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Summary

FDA approved JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddy's Laboratories as an original ANDA, providing a generic option for phenylketonuria in BH4-res…

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Diseases / indications

• Phenylketonuria

Drugs mentioned

• JAVYGTOR (Sapropterin dihydrochloride)

Snippet

ORIG AP for JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)