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 |
New Drug Approvals Archive
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