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New Drug Approvals Archive - August 2008

August 2008

Cardene (nicardipine)

New Formulation Approved: July 31, 2008

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

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.

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).

Novolog Mix (insulin aspart and insulin aspart protamine)

New Formulation Approved: August 26, 2008

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