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FDA approval · 2026-04-15

FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Novadoz Pharmaceuticals LLC)

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Summary

FDA approves an original application for glycerol phenylbutyrate from Novadoz Pharmaceuticals LLC, a generic option for the treatment of urea cycle disorders.

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Diseases / indications

Drugs mentioned

  • Glycerol phenylbutyrate (glycerol phenylbutyrate)

Snippet

ORIG AP for GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)