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New Drug Approvals Archive - October 2009

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) 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, facial, or laryngeal 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. Berinert (C1 esterase inhibitor (human)) FDA Approval History
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 Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) FDA Approval History
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 Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History
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 Fluarix (influenza virus vaccine, inactivated) FDA Approval History
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 Twynsta (telmisartan and amlodipine) FDA Approval History
October 19	Votrient (pazopanib) Tablets Date of Approval: October 19, 2009 Company: GlaxoSmithKline Treatment for: Renal Cell Carcinoma, Soft Tissue Sarcoma Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma and advanced soft tissue sarcoma. FDA Approves GlaxoSmithKline’s Votrient for Advanced Renal Cell Cancer Votrient (pazopanib) FDA Approval History
October 22	Colcrys (colchicine) New Indication Approved: October 16, 2009 FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares Colcrys (colchicine) FDA Approval History
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 Arzerra (ofatumumab) FDA Approval History
January 3	Berinert (C1 esterase inhibitor (human)) New Indication Approved: December 22, 2011 CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema Berinert (C1 esterase inhibitor (human)) FDA Approval History
April 26	Votrient (pazopanib) New Indication Approved: April 26, 2012 FDA Approves Votrient for Advanced Soft Tissue Sarcoma Votrient (pazopanib) FDA Approval History
January 19	Arzerra (ofatumumab) Labeling Revision Approved: January 15, 2016 Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL Arzerra (ofatumumab) FDA Approval History
August 31	Arzerra (ofatumumab) New Indication Approved: August 30, 2016 Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL Arzerra (ofatumumab) FDA Approval History

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