New Drug Approvals Archive
Patient Population Altered: November 29, 2007
Kuvan (sapropterin dihydrochloride) Tablets
Date of Approval: December 13, 2007
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.
Date of Approval: December 17, 2007
Bystolic (nebivolol) is a once daily beta blocker approved for the treatment of hypertension.
New Dosage Regimen: December 17, 2007