PEDIATRIC ADVISORY COMMITTEE TO DISCUSS ADVERSE EVENTS FOR SIX DRUGS

The FDA's Pediatric Advisory Committee is convening in February to discuss adverse event reporting for six brand drugs.

The products on the agenda include Novartis' Lotensin (benazepril), Baxter Pharmaceutical's Brevibloc (esmolol), GlaxoSmithKline's Malarone (atovaquone/proguanil), Pfizer's Viracept (nelfinavir), Roche's Xenical (orlistat) and Bristol-Myers Squibb's Glucovance (glyburide/metformin).

Under Section 17 of the Best Pharmaceuticals for Children Act (BPCA), the committee is required to review adverse events that occur during the first year after a drug receives a period of market exclusivity.

The two-day meeting, scheduled to occur Feb. 14 15, will also include a discussion of how the process and content of the committee's adverse event reviews under BPCA can be improved.

For more information, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/oc04323-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc04323-nm00001.pdf).