Orlistat gains FDA Advisory Committee approval

GlaxoSmithKline may have engineered the first Rx-to-OTC switch of a weight-loss drug, and, indeed, orlistat (brand name Alli, pronounced "ally"), if finally approved by the FDA for over-the-counter (OTC) use, will be the only drug for weight loss that is FDA-approved for consumer use without a prescription. ZBI's Dr. Cecilia A. Hale was Glaxo's lead statistician in preparing for the January 23 FDA Advisory Committee meeting that approved orlistat. GSK also assigned Dr. Hale a key role at the Advisory Committee meeting. [Continue]

FDA Advisory Committee chair and Professor of Medicine and Pharmacology at Vanderbilt University School of Medicine Dr. Alastair Wood stated, "I think the drug is safe enough to be OTC. It's an OTC indication. Although there are some i's that need to be dotted and t's crossed, it's suitable for OTC use," as reported by the Associated Press. The committee did have concerns with orlistat safety in the OTC marketplace and requested that FDA require the company to conduct post-marketing studies as well as modify the labeling that has been submitted to the agency. Roche currently markets orlistat as an Rx product under the Xenical brand and licenses orlistat to Glaxo.