New Drug Approvals Archive

New Drug Approvals: September 2007

September 4
Aloxi (palonosetron)

New Dosage Regimen: August 30, 2007

MGI Pharma and Helsinn Announce Aloxi sNDA Approval Allowing for Repeated Dosing for Cancer Patients Receiving Multiple Day Chemotherapy Regimens
 
September 6
Totect (dexrazoxane)

Date of Approval: September 6, 2007

Company: TopoTarget A/S

Treatment for: Anthracycline Extravasation

Totect (dexrazoxane) is a topoisomerase inhibitor used as a detoxifying agent for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

Totect Approved in the United States
 
September 26
Azor (amlodipine and olmesartan) Tablets - formerly amlodipine and olmesartan

Date of Approval: September 26, 2007

Company: Daiichi Sankyo, Inc.

Treatment for: Hypertension

Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Azor is indicated for the treatment of hypertension.

Azor Receives FDA Approval for Treatment of High Blood Pressure
 
September 28
Afluria (influenza virus vaccine)

Date of Approval: September 28, 2007

Company: CSL Biotherapies

Treatment for: Influenza Prophylaxis

Afluria (influenza virus vaccine) is an inactivated influenza virus vaccine, indicated for active immunization of persons ages 18 years and older against influenza disease.

CSL Biotherapies Announces FDA Marketing Approval of Afluria
 
May 13
Azor (amlodipine and olmesartan)

New Indication Approved: May 11, 2009

Azor Receives FDA Approval as First-Line Treatment for High Blood Pressure
 

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