FDA's NDAC to consider OTC use of tetrahydrolipstatin

The US Food and Drug Administration has issued a notice in the Federal Register announcing that its Nonprescription Drugs Advisory Committee will meet jointly with its Endocrinologic and Metabolic Drugs Advisory Committee January 23 for the purpose of considering the safety and efficacy of a new drug application submitted by GlaxoSmithKline that proposes the over-the-counter use of Orlistat (tetrahydrolipstatin) capsules. In its application, GSK recommends a 60mg dosage to promote weight loss in adults when used along with a reduced-calorie, low-fat diet.

According to FDA, the background materials will be posted to its web site no later than one day prior to the meeting. Persons wishing to submit written comments on the subject matter or to present orally during the meeting should contact Darrell Lyons at the NDAC by January 13, 2006.