NOV 4 AMDAC

The US FDA has posted details, including company and FDA Briefing Materials, for the Friday, November 4, 2016 Antimicrobial Drugs Advisory Committee (AMDAC) meeting. The Committee will discuss new drug applications 209006 and 209007, solithromycin capsules and solithromycin for injection, respectively, sponsored by Cempra Pharmaceuticals, Inc. (Cempra) for the proposed indication of treatment of community-acquired bacterial pneumonia (CABP).

See the SAC Tracker report