Posted by Michael Wonder on 30 Dec 2016
Cempra receives complete response letter from FDA for solithromycin NDAs
29 December 2016 - Cempra Pharmaceuticals today announced that the company has received a complete response letter from the U.S. FDA relating to the company's new drug applications for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia in adults.
The CRL states that the FDA cannot approve the applications in their present form and notes that additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies are required before the applications may be approved.
The FDA did not request any further information on solithromycin efficacy for community-acquired bacterial pneumonia in the complete response letter.
