New Drug Approvals Archive
New Drug Approvals: March 2008
| March 3 | Pristiq (desvenlafaxine) Extended-Release Tablets Date of Approval: February 29, 2008 Company: Wyeth Pharmaceuticals Treatment for Depression Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause. FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder |
| March 3 | Aloxi (palonosetron)
New Indication Approved: February 29, 2008 FDA Approves Aloxi (palonosetron HCl) Injection for Prevention of Postoperative Nausea and Vomiting |
| March 10 | Levoleucovorin (levoleucovorin) for Injection - formerly Isovorin Date of Approval: March 7, 2008 Company: Spectrum Pharmaceuticals, Inc. Treatment for Folic Acid Antagonist Overdose, Methotrexate Rescue Levoleucovorin is a folate analog and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin rescue is used after the administration of high-dose methotrexate in osteosarcoma. Levoleucovorin is also used to treat inadvertent overdosage of folic acid antagonists. FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug |
| March 11 | Perrigo Company Receives Final Approval on Clobetasol Propionate Foam |
| March 12 | FDA Approval for Autoinjector |
| March 19 | Artiss (fibrin sealant (human)) Frozen solution and lyophilized powder for solution for topical application Date of Approval: March 19, 2008 Company: Baxter Healthcare Corporation Treatment for Burns - External Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. FDA Approves Artiss Medical Adhesive to Treat Burn Patients |
| March 20 | Treanda (bendamustine hydrochloride) Injection Date of Approval: March 20, 2008 Company: Cephalon, Inc. Treatment for Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent non-Hodgkin's lymphoma. Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia |
New Drug Approvals Archive
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