In Brief: Ucyclyd Buphenyl
Executive Summary
Ucyclyd Buphenyl: Tablet version of orphan drug sodium phenylbutyrate receives FDA approval May 13. Buphenyl powder was approved on April 30 ("The Pink Sheet" May 13, T&G-1). Both versions are indicated for chronic management of urea cycle disorders. Hunt Valley, Md.-based Ucyclyd submitted the NDAs in February 1995...
|
Ucyclyd Buphenyl: Tablet version of orphan drug sodium phenylbutyrate receives FDA approval May 13. Buphenyl powder was approved on April 30 ("The Pink Sheet" May 13, T&G-1). Both versions are indicated for chronic management of urea cycle disorders. Hunt Valley, Md.-based Ucyclyd submitted the NDAs in February 1995.... |