BioCentury
ARTICLE | Clinical News

Cempra withdraws Solithera MAA

May 19, 2017 12:19 AM UTC

Cempra Inc. (NASDAQ:CEMP) withdrew an MAA for oral and IV formulations of Solithera solithromycin (CEM-101) to treat community-acquired bacterial pneumonia (CABP) after receiving EMA’s Day 120 questions. The company believes EMA will require additional data for approval.

FDA issued complete response letters in December for Cempra’s NDAs for IV and oral Solithera in the indication and recommended the company conduct an additional safety study in about 9,000 patients (see BioCentury, Jan. 9). The company plans to resubmit both applications with the additional data requested by FDA...

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