Posted by Michael Wonder on 29 Mar 2017
Cempra withdraws solithromycin marketing authorisation application in Europe
28 March 2017 - Company plans to resubmit application with additional data, in alignment with FDA strategy.
Cempra today announced that the company has withdrawn its marketing authorisation application seeking EMA approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired pneumonia in adults.
Based on the Day 120 questions Cempra received from the EMA, the company believes additional data would be required. By withdrawing the application at this time, Cempra will conserve considerable financial resources, and it will allow the company to align its strategy to provide additional data to both the EMA and U.S. FDA to support potential approval.
