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New Drug Approvals Archive

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August 2008

August 1

Cardene (nicardipine)

New Formulation Approved: July 31, 2008

August 4

Exforge (amlodipine and valsartan)

New Indication Approved: July 23, 2008

Exforge (amlodipine and valsartan) FDA Approval History

August 1

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.

Cleviprex (clevidipine butyrate) FDA Approval History

August 11

Viread (tenofovir disoproxil fumarate)

New Indication Approved: August 11, 2008

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) FDA Approval History

August 21

Vidaza (azacitidine)

New Indication Approved: August 20, 2008

Vidaza (azacitidine) FDA Approval History

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).

Nplate (romiplostim) FDA Approval History

August 25

Aloxi (palonosetron)

New Dosage Form Approved: August 22, 2008

August 26

Novolog Mix (insulin aspart and insulin aspart protamine)

New Formulation Approved: August 26, 2008

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