Cempra's solithromycin gets Nov. 4 FDA panel

FDA's Antimicrobial Drugs Advisory Committee will meet Nov. 4 to discuss NDAs for oral solithromycin ( CEM-101) and IV solithromycin from Cempra Inc. (NASDAQ:CEMP) to treat community-acquired bacterial pneumonia (CABP). The PDUFA dates for the oral and IV formulations are Dec. 27 and 28, respectively. Solithromycin is a fluoroketolide/macrolide antibiotic.

Cempra has exclusive, worldwide rights from Merck & Co. Inc. (NYSE:MRK) to solithromycin outside countries in the Association of Southeast Asian Nations (ASEAN). ...