Glaxo still expected to sell weight-loss drug OTC
The FDA declined to allow GlaxoSmithKline to sell the weight-loss drug Xenical (orlistat) without a prescription, but the company said it still expects to introduce an OTC version of the drug by the end of the year.
The FDA declined to allow GlaxoSmithKline to sell the weight-loss drug Xenical (orlistat) without a prescription, but the company said it still expects to introduce an OTC version of the drug by the end of the year. Glaxo said it received a so-called approvable letter from the FDA, but did not say what the FDA would require in order to allow orlistat to be sold OTC. The company plans to market the drug under the name Alli. Meanwhile, the consumer group Public Citizen wants the FDA to ban orlistat because it claims that the obesity treatment has been linked to precancerous lesions in the large intestine.
To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.
To go to the Drug Topics homepage, click here http://www.drugtopics.com.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
