New Drug Approvals Archive
New Drug Approvals: September 2008
| September 3 | Omnitrope (somatropin (rDNA origin))
New Formulation Approved: August 25, 2008 Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge |
| September 8 | Akorn, Inc. Announces First Lyophilized Product Approval For Decatur, IL: IC-Green for Injection, USP |
| September 15 | Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)
New Indication Approved: September 12, 2008 FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers |
| September 15 | Sancuso (granisetron) Transdermal Patch Date of Approval: September 12, 2008 Company: ProStrakan Group plc Treatment for Nausea/Vomiting -- Chemotherapy Induced Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy. FDA Approves Sancuso, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy |
| September 15 | Keppra (levetiracetam)
New Dosage Form Approved: September 12, 2008 Keppra XR Approved in the U.S. |
| September 15 | Gamunex (immune globulin intravenous (human))
New Indication Approved: September 12, 2008 FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States |
| September 19 | AdreView (iobenguane I 123) Injection Date of Approval: September 19, 2008 Company: GE Healthcare Treatment for Diagnostic AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults. FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults |
| September 23 | Nasacort (triamcinolone acetonide)
Patient Population Altered: September 19, 2008 FDA Approves Nasacort AQ Nasal Spray for Children Aged 2-5 years old |
| September 24 | ProAir HFA (albuterol sulfate)
Patient Population Altered: September 16, 2008 Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication |
| September 25 | Boston Scientific Announces FDA Approval of TAXUS Express2 Atom Stent System, First Drug-Eluting Stent For Small Vessels |
| September 29 | Alimta (pemetrexed)
New Indication Approved: September 26, 2008 FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval |
New Drug Approvals Archive
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