Oral solithromycin regulatory update

FDA granted Fast Track designation to IV and oral solithromycin from Cempra to treat community-acquired bacterial pneumonia (CABP). Both formulations of the fluoroketolide/macrolide antibiotic are in Phase III testing for CABP, with an NDA submission planned for next year. IV and oral solithromycin have Qualified Infectious Disease Product (QIDP) designation to treat CABP. ...