Hospira, Inc. – FDA CRL

Hospira, Inc. received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application (NDA 219112) for Diazepam Injection. The FDA determined that the application cannot be approved in its present state due to identified deficiencies. Key issues noted include concerns related to "Product Quality" and "Nonclinical" aspects, requiring further detail or resolution. Additionally, Hospira must submit revised draft "Carton and Container Labeling." A primary requirement involves a comprehensive "Safety Update," as per 21 CFR 314.50(d)(5)(vi)(b), detailing significant safety profile changes, incorporating new safety data, retabulating adverse events and trial discontinuations, and providing case reports for serious adverse events or deaths. The update must also include updated exposure information, a worldwide safety summary, and English translations of foreign labeling. The FDA reserved comments on "Prescribing Information" until other deficiencies are resolved. Hospira is required to resubmit the application within one year, fully addressing all outlined issues. The company may request a meeting to discuss approval requirements, and the product cannot be legally marketed until written approval is granted.