FDA’s Vaccines and Related Biological Products Advisory Committee gave GlaxoSmithKline‘s Cervarix a favorable recommendation yesterday, and also recommended that Merck‘s Gardasil receive an indication for boys and men. FDA is not obligated to follow the recommendation of its advisory committees, though it usually does. Cervarix has not yet been approved in the US. Gardasil was approved for women and girls in 2006.
Salix Pharmaceuticals received an FDA approval for Metozolv (metoclopramide), a treatment for diabetic gastroparesis and gastroesophageal reflux disease (GERD). The drug was approved for short-term use, from four to 12 weeks.
