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 |
New Drug Approvals Archive
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