FDA Approved: PHEBURANE — Original Application (Medunik USA)

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Summary

FDA approved PHEBURANE (sodium phenylbutyrate) under Medunik USA's original NDA for the treatment of urea cycle disorders to prevent hyperammonemia.

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Diseases / indications

• Urea Cycle Disorder

Drugs mentioned

• Pheburane (sodium phenylbutyrate)

Snippet

ORIG AP for PHEBURANE (SODIUM PHENYLBUTYRATE)