New brand drugs approved in February 2008

[chantell.reagan]

New brands approved by the FDA in February 2008:

Arcalyst (rilonacept) by Regeneron

•Indication: interleukin-1 blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older
•Prescribing information: http://www.fda.gov/cder/foi/label/2008/125249lbl.pdf

Luvox CR (fluvoxamine extended release capsules) by Solvay

•Indications: social anxiety disorder and obsessive-compulsive disorder
•Prescribing information: http://www.fda.gov/cder/foi/label/2008/022033lbl.pdf

Pristiq (desvenlafaxine) by Wyeth

•Indication: selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD)
•Prescribing information: http://www.fda.gov/cder/foi/label/2008/021992lbl.pdf

Simcor (niacin/simvastatin) by Abbott

•Indications: Reduce elevated total–C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate AND to reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate
•Prescribing information: http://www.fda.gov/cder/foi/label/2008/022078lbl.pdf

Sources:
Caremark TrendsRx® Drug Pipeline and News. Available at: https://www.caremark.com/wps/portal/...s=CMS-2-017604

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA