Hikma Pharmaceuticals USA Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for New Drug Application (NDA) 219357 to Hikma Pharmaceuticals USA Inc., indicating the application cannot be approved in its present form. The primary reason for non-approval stems from unresolved product quality issues. While specific comments on proposed prescribing information, carton/container labeling, and the proprietary name are reserved, these aspects will require attention once the core deficiencies are addressed.

A critical requirement for resubmission involves a comprehensive safety update, as mandated by 21 CFR 314.50(d)(5)(vi)(b). Hikma must provide detailed data from all nonclinical and clinical studies, describing any significant changes in the safety profile, presenting new and combined safety data with comparative frequencies, and submitting case report forms and narrative summaries for subject deaths or trial discontinuations due to adverse events. Updated exposure information, a summary of worldwide safety experience, and English translations of current approved foreign labeling are also required.

Under 21 CFR 314.110, Hikma has one year to fully address all identified deficiencies and resubmit the application, clearly labeled as a "RESUBMISSION." The company also has the option to request a meeting with the FDA to discuss the necessary steps for approval. The product cannot be legally marketed until written approval of the NDA is received.