FDA CRL - Accord Healthcare Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Accord Healthcare Inc. for its New Drug Application (NDA 218762) concerning paclitaxel protein-bound particles for injectable suspension. The FDA found the application unapprovable in its current state due to significant deficiencies. Key issues include unresolved observations from surveillance inspections of both the drug product and drug substance manufacturing facilities. Satisfactory resolution of these manufacturing practice deficiencies is mandatory for approval. Furthermore, Accord Healthcare is required to provide a comprehensive safety update, in accordance with 21 CFR 314.50(d)(5)(vi)(b). This update must detail any significant changes in the safety profile, incorporate new clinical trial data, compare adverse event frequencies, and provide updated worldwide safety experience, among other specific requirements. Comments on proposed prescribing information, carton, and container labeling are reserved until these primary issues are adequately addressed. Accord Healthcare must resubmit the application within one year, fully addressing all identified deficiencies, or take other available actions, such as requesting an extension. The company may also request a meeting with the FDA to discuss the necessary steps for approval. The product cannot be legally marketed until written approval is granted by the FDA.