New Drug Approvals Archive - February 2008
See also: New Indications and Dosage Forms for February 2008
February 2008
Simcor (niacin ER and simvastatin) Tablets
Date of Approval: February 15, 2008
Company: Abbott
Treatment for: High Cholesterol
Marketing Status: Discontinued
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.
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.
Arcalyst (rilonacept) Injection - formerly Interleukin-1 Trap
Date of Approval: February 27, 2008
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis
Arcalyst (rilonacept) is an interleukin-1 inhibitor indicated for the:
- treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older
- maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more
- treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.
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.
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