Solithromycin is designated by FDA as a Qualified Infectious Disease Product
FDA has granted Priority Review and Fast Track designation for solithromycin IV and capsules for the treatment of CABP
Two NDAs submitted, one for intravenous and one for oral capsules
CHAPEL HILL, N.C., May 01, 2016 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the completion of its rolling submission of the New Drug Applications (NDA) for solithromycin to the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP). Based on the Qualified Infectious Disease Product (QIDP) designation by the FDA of solithromycin, Cempra has Priority Review and has been granted Fast Track for both the oral capsule and intravenous formulations for the treatment of CABP, which could result in an FDA decision on solithromycin’s NDA within eight months, or by the end of 2016, based on the Prescription Drug User Fee Act (PDUFA) performance goals.