New Drug Approvals Archive - August 2008
New Formulation Approved: July 31, 2008
Exforge (amlodipine and valsartan)
New Indication Approved: July 23, 2008
Cleviprex (clevidipine butyrate) Injectable Emulsion
Date of Approval: August 1, 2008
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
Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.
New Indication Approved: August 20, 2008
Date of Approval: August 22, 2008
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
New Dosage Form Approved: August 22, 2008
Novolog Mix (insulin aspart and insulin aspart protamine)
New Formulation Approved: August 26, 2008