Oral Solithera regulatory update

FDA issued a complete response letter to Cempra for its NDAs for oral and IV Solithera solithromycin to treat community acquired pneumonia (CABP). The company said the letter recommended an additional safety study in about 9,000 patients to evaluate Solithera's potential for drug-induced liver injury. The letter also said that if approved, the fluoroketolide/macrolide antibiotic's label would include "adequate information" about the compound's potential for hepatotoxicity and limitations on its use, even in absence of new signals from the proposed safety study. The agency will also require postapproval safety monitoring. The letter also cited manufacturing deficiencies...