FDA CRL - Hospira, Inc.

The Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Hospira, Inc. for its New Drug Application (NDA 209191) for Bortezomib for Injection, 2.5 mg/vial, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the application cannot be approved in its current form due to several outstanding issues. A primary concern stems from deficiencies identified during a recent inspection of the manufacturing facility. The satisfactory resolution of these manufacturing practice issues is a prerequisite for approval. Additionally, the FDA requires a comprehensive safety update, encompassing new nonclinical and clinical study data, detailed analysis of adverse events, reasons for trial discontinuations, and a summary of worldwide safety experience, including updated exposure information and foreign labeling translations. The agency also reserved comment on the proposed prescribing information, advising Hospira to adhere to specific regulatory guidelines for content and format, including submission in structured product labeling (SPL) format. Furthermore, Hospira must resubmit draft carton and container labeling identical to previously provided versions. Hospira, Inc. is required to fully address all deficiencies within one year by resubmitting the application, clearly marked as a complete response. The drug product cannot be legally marketed until written approval is granted. The company may also request a meeting with the FDA to discuss the necessary next steps for approval.