Accord Healthcare Inc. – FDA CRL

Accord Healthcare Inc. has received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application (NDA) for paclitaxel protein-bound particles for injectable suspension. The FDA cannot approve the application due to unaddressed manufacturing deficiencies and outstanding data requirements. The primary issues involve unsatisfactory outcomes from Current Good Manufacturing Practice (CGMP) inspections at both the drug product and drug substance manufacturing facilities. The FDA identified deficiencies at both sites, necessitating satisfactory responses to the FDA Form 483 findings. Achieving CGMP compliance, potentially through re-inspections and successful Pre-Approval Inspections (PAIs), is mandatory before approval. Furthermore, Accord Healthcare must provide a comprehensive safety update, as per regulatory requirements (21 CFR 314.50(d)(5)(vi)(b)), detailing any significant safety profile changes, incorporating new nonclinical and clinical safety data, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. Comments on proposed prescribing information and carton/container labeling are reserved until these primary issues are resolved. Accord Healthcare is required to resubmit the application, fully addressing all identified deficiencies, or take other appropriate action within one year (21 CFR 314.110), clearly marking it as a complete response. The product cannot be legally marketed without formal FDA approval.