New Drug Approvals Archive

Diovan (valsartan)

Patient Population Altered: November 29, 2007

• FDA Approves Diovan for Treatment of High Blood Pressure in Children

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.

• BioMarin Announces FDA Approval for Kuvan

Kuvan (sapropterin dihydrochloride) FDA Approval History

Bystolic (nebivolol)

Date of Approval: December 17, 2007
Company: Mylan Laboratories Inc. and Forest Laboratories
Treatment for: Hypertension

Bystolic (nebivolol) is a once daily beta blocker approved for the treatment of hypertension.

• Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension

Bystolic (nebivolol) FDA Approval History

Ranexa (ranolazine)

New Dosage Regimen: December 17, 2007

• FDA Approves New Mechanism of Action Labeling for Ranexa

Ranexa (ranolazine) FDA Approval History