Kuvan Approval History
FDA Approved: Yes (First approved December 13, 2007)
Brand name: Kuvan
Generic name: sapropterin dihydrochloride
Dosage form: Tablets
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria
Kuvan (sapropterin dihydrochloride) is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase to metabolize phenylalanine (Phe). Kuvan is indicated for the treatment of phenylketonuria, an inherited metabolic disease caused by a deficiency of the enzyme phenylalanine hydroxylase.
Development History and FDA Approval Process for Kuvan
|Dec 13, 2007||BioMarin Announces FDA Approval for Kuvan|
|Jul 26, 2007||Kuvan Receives Priority Review Status from FDA|
|May 24, 2007||BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)|