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FDA approval · 2018-12-21

FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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Summary

FDA approved Lupin Pharmaceuticals' supplemental submission for glycerol phenylbutyrate, a nitrogen-scavenging therapy for urea cycle disorders.

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Diseases / indications

Drugs mentioned

  • Glycerol phenylbutyrate (glycerol phenylbutyrate)

Snippet

SUPPL AP for GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)