New Drug Approvals Archive - February 2008
Asmanex (mometasone furoate)
Patient Population Altered: February 4, 2008
Simcor (niacin ER and simvastatin) Tablets
Date of Approval: February 15, 2008
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.
Xyzal (levocetirizine dihydrochloride)
New Dosage Form Approved: January 28, 2008
Xyntha (antihemophilic factor (recombinant), plasma/albumin free )
Date of Approval: February 21, 2008
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
New Dosage Form Approved: February 27, 2008
Arcalyst (rilonacept) Injection - formerly Interleukin-1 Trap
Date of Approval: February 27, 2008
Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
Patient Population Altered: February 27, 2008
Pristiq (desvenlafaxine) Extended-Release Tablets
Date of Approval: February 29, 2008
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