New Drug Approvals Archive
New Drug Approvals: February 2008
| February 4 | Asmanex (mometasone furoate)
Patient Population Altered: February 4, 2008 FDA Approves Asmanex Twisthaler (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 |
| February 15 | 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 | Xyzal (levocetirizine dihydrochloride)
New Dosage Form Approved: January 28, 2008 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 | Humira (adalimumab)
New Indication Approved: February 21, 2008 Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis |
| February 25 | Avastin (bevacizumab)
New Indication Approved: February 22, 2008 FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer |
| February 28 | Nexium (esomeprazole)
New Dosage Form Approved: February 27, 2008 FDA Approves Nexium for Use in Children Ages 1-11 Years |
| February 27 | Arcalyst (rilonacept) Injection - 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 | Abilify (aripiprazole)
Patient Population Altered: February 27, 2008 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) |
| February 29 | 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 |
New Drug Approvals Archive
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