2 Min Read
Dec 29 (Reuters) - Cempra Inc
* Cempra receives complete response letter from FDA for solithromycin NDAs
* FDA did not request any further information on solithromycin efficacy for CABP in CRL
* Says plans to request a meeting with FDA as soon as possible to discuss issues identified in a complete response letter
* Comprehensive plan for post-marketing safety assessment including an enhanced pharmacovigilance program would also be required
* To address the deficiency, FDA is recommending a comparative study to evaluate safety of solithromycin in patients with CABP
* During inspections of Wockhardt Limited and Hospira manufacturing facilities, FDA field investigator conveyed deficiencies to representatives
* CRL states that FDA cannot approve NDAs in their present form
* CRL notes that additional clinical safety information and satisfactory resolution of manufacturing facility inspection deficiencies required
* Based on their review of NDAs, CRL stated that FDA determined risk of hepatotoxicity had not been adequately characterized.
* Says plans to provide FDA with an update on manufacturing progress at Uquifia
* Details on the deficiencies were not provided in CRL
* Cempra inc says "is committed to working with FDA to achieve approval of solithromycin as quickly as possible"
* Cempra - also plans to provide FDA with update on manufacturing progress at Uquifia, an alternate GMP manufacturing facility for solithromycin API Source text for Eikon: Further company coverage: