FDA Update: Week Of August 16, 2010

By Lori Clapper, Web Editor

Meningitis Risk
The FDA warned that Lamictal (lamotrigine), a drug used to treat seizures and bipolar disorder, may cause aseptic meningitis. GlaxoSmithKline, the drug's manufacturer, is working with the FDA to update the prescribing information and patient medication guide to include this risk. The FDA became aware of this risk through adverse monitoring with GSK between 1994 and 2009.

Read the FDA announcement about Lamictal.

Advisory Committee Updates
The FDA has updated 2010 meeting materials of the Oncologic Drugs Advisory committee. Discussions at the committee meetings included supplemental biologics license applications for Genentech's Avastin, and the FDA's backup presentation of Pfizer's Revatio.

New And Generic Drug Approvals
Visit the FDA's website to see what's been approved this month, including medications from Takeda, Merck, and Ranbaxy.