New Drug Approvals Archive
New Drug Approvals: August 2008
| August 1 | Cardene (nicardipine)
New Formulation Approved: July 31, 2008 FDA Approves New Cardene Formulation |
| August 4 | Exforge (amlodipine and valsartan)
New Indication Approved: July 23, 2008 Single-Pill Combinations Diovan HCT and Exforge Approved in US as First-Line Treatments for High Blood Pressure |
| August 4 | Cleviprex (clevidipine butyrate) Injectable Emulsion Date of Approval: August 1, 2008 Company: The Medicines Company Treatment for Hypertension Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable. The Medicines Company’s Cleviprex Receives FDA Approval |
| August 11 | Viread (tenofovir disoproxil fumarate)
New Indication Approved: August 11, 2008 U.S. Food and Drug Administration Approves Viread for Chronic Hepatitis B in Adults |
| August 15 | Xenazine (tetrabenazine) Date of Approval: August 15, 2008 Company: Prestwick Pharmaceuticals, Inc. Treatment for Huntington’s Chorea Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease. Xenazine (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease |
| August 21 | Vidaza (azacitidine)
New Indication Approved: August 20, 2008 Vidaza Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS |
| August 22 | Nplate (romiplostim) Date of Approval: August 22, 2008 Company: Amgen Inc. Treatment for Idiopathic (Immune) Thrombocytopenic Purpura Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP |
| August 25 | Aloxi (palonosetron)
New Dosage Form Approved: August 22, 2008 FDA Approves Aloxi (palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting |
| August 26 | Novolog Mix (insulin aspart and insulin aspart protamine)
New Formulation Approved: August 26, 2008 FDA Approves Novolog Mix 50/50 |
New Drug Approvals Archive
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