BioCentury
ARTICLE | Clinical News

Rextoro regulatory update

July 21, 2014 7:00 AM UTC

FDA’s Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees will meet on Sept. 18 to discuss an NDA from Clarus for Rextoro, an oral testosterone under review as testosterone replacement therapy in males with primary or hypogonadotropic hypogonadism. The product has a Nov. 3 PDUFA date. ...