December 29, 2016 / 12:18 PM / 7 months ago

BRIEF-Cempra receives complete response letter from FDA for solithromycin NDAs

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:

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