New Drug Approvals Archive

New Drug Approvals: December 2007

December 3
Diovan (valsartan)

Patient Population Altered: November 29, 2007

FDA Approves Diovan for Treatment of High Blood Pressure in Children
 
December 13
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
 
December 17
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
 
December 19
Ranexa (ranolazine)

New Dosage Regimen: December 17, 2007

FDA Approves New Mechanism of Action Labeling for Ranexa
 

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