The FDA has approved GlaxoSmithKline’s orlistat as an OTC weight-loss aid for overweight adults.
OTC orlistat will be sold under the brand name Alli and is indicated for use in adults ages 18 years and older in conjunction with a reduced-calorie, low-fat diet, and exercise program, the FDA said in a statement.
Orlistat first received FDA approval in 1999 as the branded prescription product Xenical, which is sold in the US by Roche.
Prescription Xenical is available in 120-mg capsule form and will continue to remain available as a prescription product. Alli will be sold in a 60-mg dose, over-the-counter.
“We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes,” said Dr. Douglas Throckmorton, deputy director for FDA’s Center for Drug Evaluation and Research. “OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health.”
The FDA said it approved OTC orlistat based on the review of GSK’s safety data after it submitted the product for consideration by an FDA advisory committee in January 2006. The committee voted in favor of OTC approval.
Meanwhile, GSK said it expects to launch five new products this year, the drugmaker told investors as it announced its 2006 financial results.
“We now have over 30 significant product opportunities in phase III development or registration, including five major new products planned for launch this year,” CEO JP Garnier said in a statement.
GSK plans to launch Tykerb for breast cancer during the first half of 2007; Allermist/Avamys for allergic rhinitis, also during the first half the year; Coreg for heart conditions during the first quarter; and Trexima for migraine during the second half of 2007. The firm also expects to file for approval for its cervical cancer vaccine Cervarix in April.
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