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 4 | ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) Date of Approval: August 31, 2007 Company: Acambis Inc. Treatment for Smallpox Prophylaxis ACAM2000 is live vaccinia virus smallpox vaccine intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks. FDA Approves ACAM2000 Vaccine for Protection Against Smallpox |
| September 7 | Totect (dexrazoxane) Date of Approval: September 6, 2007 Company: TopoTarget A/S Treatment for Anthracycline Extravasation Totect 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 14 | FDA Approves Lilly's Osteoporosis Drug Evista (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women |
| September 17 | FDA Approves Soma (carisoprodol) 250 mg |
| September 19 | FDA Approves Expanded Label for FluMist to Include Children Two to Five Years of Age |
| September 19 | Perrigo Company Announces FDA Approval for Ciclopirox Topical Solution |
| September 20 | FDA Approves Expanded Labeling for Campath to Include First-line Treatment for Leading Form of Adult Leukemia |
| September 21 | Norditropin Approved for Treatment of Children with Short Stature Associated with Turner Syndrome |
| September 27 | FDA Approves New 300mg Loading Dose Tablet for Plavix |
| September 27 | 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 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 |
New Drug Approvals Archive
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