FDA joint advisory committee gives nod to OTC orlistat
The FDA's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend approval of GlaxoSmithKline's orlistat 60-mg capsules for over-the-counter use in the U.S. OTC orlistat, which would be marketed under the brand name Alli, would be the only FDA-approved weight-loss medication available OTC. Alli would be indicated for use by overweight adults along with a reduced-calorie, low-fat diet. Xenical (orlistat 120-mg capsules) will remain available by prescription for obesity management and for those who should be under the care of a physician.
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.
