FDA grants “fast track” designation to pneumonia drug

By Dr Deepu

FDA grants “fast track” designation to pneumonia drug

The Triangle (NC) Business Journal (8/19, deBruyn, Subscription Publication) reports that Chapel Hill-based drug developer Cempra Inc. received “Fast Track” designation from the FDA to expedite the review process for “Cempra’s experimental drug solithromycin, a treatment for community acquired bacterial pneumonia (CABP).” The drug is “currently in Phase 3 development for the treatment of CABP and Cempra plans a New Drug Application submission in 2016.”