New Drug Approvals Archive - August 2008
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
Cleviprex (clevidipine butyrate) Injectable Emulsion
Date of Approval: August 1, 2008
Company: The Medicines Company
Treatment for: Hypertension
Cleviprex (clevidipine) 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.
Viread (tenofovir disoproxil fumarate)
New Indication Approved: August 11, 2008
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
New Indication Approved: August 20, 2008
Read more: Vidaza (azacitidine) FDA Approval History
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).
Read more: Nplate (romiplostim) FDA Approval History
New Dosage Form Approved: August 22, 2008
Novolog Mix (insulin aspart and insulin aspart protamine)
New Formulation Approved: August 26, 2008