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FDA approval · 2021-12-02

FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Par Health USA, LLC)

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Summary

FDA approved the original application for glycerol phenylbutyrate oral to treat patients with urea cycle disorders and help prevent elevated ammonia levels.

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Diseases / indications

Drugs mentioned

  • Glycerol phenylbutyrate (glycerol phenylbutyrate)

Snippet

ORIG AP for GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE ORAL)