Urea Cycle Disorders

• FDA approval · 2013-02-01
  FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved glycerol phenylbutyrate under Original Application (NDA 203284) from Lupin Pharmaceuticals for the treatment of urea cycle diso…

• FDA approval · 2009-03-31
  FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) submitted by Horizon Therapeutics USA, Inc.