FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Micro Labs Limited)

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Summary

FDA approves an original-application Abbreviated New Drug Application for sapropterin dihydrochloride by Micro Labs Limited. This approval makes a generic versi…

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Diseases / indications

• Dihydropteridine Reductase Deficiency
• Hyperphenylalaninemia
• Phenylketonuria
• Tetrahydrobiopterin Deficiency

Drugs mentioned

• Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)