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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.

Read more: Cleviprex (clevidipine butyrate) FDA Approval History

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.

Read more: Xenazine (tetrabenazine) FDA Approval History

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).

Read more: Nplate (romiplostim) FDA Approval History

Novolog Mix (insulin aspart and insulin aspart protamine)

New Formulation Approved: August 26, 2008

New Drug Approvals Archive