CompleoTRT regulatory update

FDA extended by 3 months the PDUFA date for an NDA for CompleoTRT to treat testosterone deficiency in men. The new PDUFA date is May 28; it was Feb. 28. Trimel said the agency needs more time to review the application after the company amended the proposed label of the bioadhesive intranasal gel formulation of testosterone to reflect thrice-daily dosing. Trimel said FDA considered the change a major amendment. ...