New Drug Approvals Archive

Cardene (nicardipine)

New Formulation Approved: July 31, 2008

• FDA Approves New Cardene Formulation

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

Exforge (amlodipine and valsartan) FDA Approval History

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.

• The Medicines Company’s Cleviprex Receives FDA Approval

Cleviprex (clevidipine butyrate) FDA Approval History

Viread (tenofovir disoproxil fumarate)

New Indication Approved: August 11, 2008

• U.S. Food and Drug Administration Approves Viread for Chronic Hepatitis B in Adults

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) Approved by FDA for Patients with Chorea Associated with Huntington's Disease

Xenazine (tetrabenazine) FDA Approval History

Vidaza (azacitidine)

New Indication Approved: August 20, 2008

• Vidaza Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS

Vidaza (azacitidine) 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).

• FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP

Nplate (romiplostim) FDA Approval History

Aloxi (palonosetron)

New Dosage Form Approved: August 22, 2008

• FDA Approves Aloxi (palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting

Novolog Mix (insulin aspart and insulin aspart protamine)

New Formulation Approved: August 26, 2008

• FDA Approves Novolog Mix 50/50