New Drug Approvals Archive
New Drug Approvals: October 2009
| October 2 | Mirena (levonorgestrel)
New Indication Approved: October 1, 2009 FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users |
| October 7 | Welchol (colesevelam HCl)
Patient Population Altered: October 2, 2009 Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia |
| October 9 | Berinert (C1 esterase inhibitor (human)) Injection Date of Approval: October 9, 2009 Company: CSL Behring Treatment for: Angioedema Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients. CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S. |
| October 16 | Crestor (rosuvastatin calcium)
Patient Population Altered: October 15, 2009 U.S. Food and Drug Administration Approves Crestor for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia |
| October 16 | Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection Date of Approval: October 16, 2009 Company: GlaxoSmithKline Treatment for: Human Papillomavirus Prophylaxis Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25). FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine |
| October 16 | Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)
New Indication Approved: October 16, 2009 FDA Approves Gardasil for Use in Boys and Young Men |
| October 16 | Elitek (rasburicase)
Patient Population Altered: October 16, 2009 FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy |
| October 19 | Fluarix (influenza virus vaccine, inactivated)
Patient Population Altered: October 19, 2009 FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use |
| October 19 | Micardis (telmisartan)
New Indication Approved: October 16, 2009 FDA Approves New Use for Micardis in Cardiovascular Risk Reduction |
| October 16 | Twynsta (telmisartan and amlodipine) Tablets Date of Approval: October 16, 2009 Company: Boehringer Ingelheim Pharmaceuticals Inc. Treatment for: Hypertension Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents. FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension |
| October 19 | Votrient (pazopanib) Tablets Date of Approval: October 19, 2009 Company: GlaxoSmithKline Treatment for: Renal Cell Carcinoma Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma. FDA Approves GlaxoSmithKline’s Votrient for Advanced Renal Cell Cancer |
| October 22 | Colcrys (colchicine)
New Indication Approved: October 16, 2009 FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares |
| October 26 | Arzerra (ofatumumab) Injection Date of Approval: October 26, 2009 Company: GlaxoSmithKline Treatment for: Chronic Lymphocytic Leukemia Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia. FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia |
New Drug Approvals Archive
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