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FDA approval · 2026-04-15

FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Teva Pharmaceuticals, Inc.)

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Summary

FDA approved glycerol phenylbutyrate for urea cycle disorders through an original application. Teva Pharmaceuticals, Inc. is the sponsor.

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Diseases / indications

Drugs mentioned

  • Glycerol phenylbutyrate (glycerol phenylbutyrate)

Snippet

ORIG AP for GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)