FDA CRL - Hospira, Inc.

The FDA issued a Complete Response Letter (CRL) to Hospira, Inc. regarding its New Drug Application (NDA) 210282 for Daptomycin for Injection, preventing its approval. The agency identified several critical deficiencies that must be resolved. Key issues include unsatisfactory resolution of manufacturing facility deficiencies noted during a recent inspection. Furthermore, the company must provide a product risk assessment to evaluate elemental impurity levels in the drug product, adhering to the ICH Q3D Elemental Impurities guidance. The FDA also mandates a comprehensive safety update, as required by 21 CFR 314.50(d)(5)(vi)(b), which involves detailing significant safety profile changes, presenting new and combined safety data, re-tabulating trial discontinuations, providing case reports for serious adverse events or deaths, and summarizing worldwide safety experience, including updated exposure and foreign labeling translations. Hospira, Inc. is required to address all deficiencies and resubmit the application, or take other actions, within one year, or request a meeting to discuss the path forward. Daptomycin for Injection cannot be legally marketed until these issues are resolved and the application receives approval.