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Home » FDA Declines to Approve Cempra’s CABP Antibiotic Solithera Due to Manufacturing, Safety Concerns
FDA Declines to Approve Cempra’s CABP Antibiotic Solithera Due to Manufacturing, Safety Concerns
The FDA refused to approve Cempra’s community-acquired bacterial pneumonia antibiotic Solithera, citing manufacturing and safety concerns in a complete response letter.