FDA CRL - NPS Pharmaceuticals Inc.

The FDA has issued a Complete Response Letter (CRL) to Spes Pharmaceuticals Inc. for its New Drug Application (NDA 216686) concerning fosaprepitant injection, 150 mg/50 mL. Submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, the application cannot be approved in its present state due to significant deficiencies in product quality, labeling, and safety.

Key issues include unresolved manufacturing deficiencies identified during recent inspections of two Pharmaceutics International, Inc. facilities. Satisfactory resolution of these facility-related concerns is a prerequisite for approval. Additionally, the prescribing information and patient package insert require revision to align with FDA electronic communications and regulatory standards, including 21 CFR 201.56(a) and (d), and 201.57. Carton and container labeling must also be updated, specifically addressing the transparency and design of the infusion container's hanger and the inclusion of readable graduation marks. The previously conditionally acceptable proprietary name, "Focinvez," requires resubmission.

Finally, a comprehensive safety update is mandated, in accordance with 21 CFR 314.50(d)(5)(vi)(6). This update must detail any significant changes in the drug's safety profile, provide new and retabulated adverse event data, include case report forms for deaths or serious adverse events, updated exposure information, and a summary of worldwide safety experience. All identified deficiencies must be adequately addressed for the NDA to be reconsidered for approval.