New Drug Approvals Archive

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December 2007

December 3

Diovan (valsartan)

Patient Population Altered: November 29, 2007

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.

Kuvan (sapropterin dihydrochloride) FDA Approval History

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 (nebivolol) FDA Approval History

December 19

Ranexa (ranolazine)

New Dosage Regimen: December 17, 2007

Ranexa (ranolazine) FDA Approval History

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