BioCentury
ARTICLE | Company News

FDA accepts Cempra NDAs

July 6, 2016 12:12 AM UTC

FDA accepted for filing NDAs from Cempra Inc. (NASDAQ:CEMP) for oral solithromycin ( CEM-101) and IV solithromycin to treat community-acquired bacterial pneumonia (CABP).

Cempra told BioCentury the two NDAs will be evaluated together and have PDUFA dates of Dec. 27 and Dec. 28. ...