FDA CRL - Sanofi-Aventis U.S. LLC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to sanofi-aventis U.S. LLC on November 12, 2020, for New Drug Application (NDA) 214429, concerning Fexinidazole tablets, 600 mg. The agency determined the application could not be approved due to several deficiencies, primarily stemming from the company's inability to submit revised product labeling during the review cycle, preventing an agreement on its content. The FDA requires sanofi-aventis to submit new draft labeling incorporating agency-proposed revisions, ensuring the Prescribing Information (PI) conforms to regulatory content and format requirements (21 CFR 201.56(a) and (d), 201.57) and is provided in structured product labeling (SPL) format. Additionally, carton and container labeling must match prior submissions. A comprehensive safety update, mandated under 21 CFR 314.50(d)(5)(vi)(b), is also required. This update must include detailed new nonclinical and clinical safety data, retabulations of adverse events, case reports for specific events, updated exposure information, and a summary of worldwide safety experience. Sanofi-aventis must address all deficiencies and resubmit the application, or take other actions per 21 CFR 314.110, within one year.