New Drug Approvals Archive
New Drug Approvals: December 2007
| December 3 | Triesence (triamcinolone acetonide) Injectable Suspension Date of Approval: November 29, 2007 Company: Alcon, Inc. Treatment for Use in Eye Surgery and Ocular Inflammatory Conditions Triesence (triamcinolone acetonide) is a synthetic corticosteroid indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Alcon Receives FDA Approval of Triesence Injectable Triamcinolone Suspension for Use in Eye Surgery |
| December 3 | FDA Approves Diovan for Treatment of High Blood Pressure in Children |
| December 4 | Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets |
| December 5 | Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc |
| December 12 | Mylan Announces Tentative FDA Approval for Lamotrigine Tablets |
| December 12 | Lannett Receives FDA Approval for Phentermine |
| December 12 | Teva Announces Approval of Generic Trileptal Tablets |
| 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 | Genzyme Announces FDA Approval of Thyrogen for Use in Thyroid Cancer Ablation |
| December 18 | 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 18 | FDA Approves Celltrion to Manufacture Orencia (abatacept) |
| 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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