New Drug Approvals Archive

New Drug Approvals: February 2008

February 1	Medtronic Receives FDA Approval for Endeavor Zotarolimus-Eluting Coronary Stent System

February 4	FDA Approves Asmanex Twisthaler (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11

February 7	HIV/AIDS Update - Epivir Tablets for Pediatric Dosing

February 19	Simcor (niacin ER and simvastatin) Tablets Date of Approval: February 15, 2008 Company: Abbott Treatment for Hyperlipidemia Simcor (Niaspan/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol. Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management

February 19	FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria

February 21	Xyntha (antihemophilic factor (recombinant), plasma/albumin free ) Date of Approval: February 21, 2008 Company: Wyeth Pharmaceuticals Inc. Treatment for Hemophilia A Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A. FDA Licenses Xyntha, a New Hemophilia Treatment

February 22	Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

February 25	FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer

February 28	FDA Approves Nexium for Use in Children Ages 1-11 Years

February 28	Arcalyst (rilonacept) - formerly Interleukin-1 Trap Date of Approval: February 27, 2008 Company: Regeneron Pharmaceuticals, Inc. Treatment for Cryopyrin-Associated Periodic Syndromes Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

February 29	FDA Approves Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder

February 29	U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

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