New Drug Approvals Archive - December 2007
Patient Population Altered: November 29, 2007
Kuvan (sapropterin dihydrochloride) Tablets
Date of Approval: December 13, 2007
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.
Date of Approval: December 17, 2007
Company: Allergan, Inc.
Treatment for: Hypertension
Bystolic (nebivolol) is a once daily beta blocker approved for the treatment of hypertension.
Read more: Bystolic (nebivolol) FDA Approval History
New Dosage Regimen: December 17, 2007
Read more: Ranexa (ranolazine) FDA Approval History