New Drug Approvals Archive - February 2008
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
Simcor (niacin ER and simvastatin) Tablets
Date of Approval: February 15, 2008
Treatment for: Hyperlipidemia
Simcor (niacin extended-release/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
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
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.
New Indication Approved: February 21, 2008
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
Read more: Avastin (bevacizumab) FDA Approval History
New Dosage Form Approved: February 27, 2008
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)
Read more: Arcalyst (rilonacept) FDA Approval History
Patient Population Altered: February 27, 2008
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.
Simcor (niacin ER and simvastatin)
New Dosage Form Approved: July 28, 2010
- Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths