FDA CRL - B & B Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Milestone Pharmaceuticals USA, Inc.'s New Drug Application (NDA 218571) for etripamil nasal spray. The FDA determined that the application cannot be approved in its current form due to several outstanding issues. A primary deficiency is the uncompleted preapproval inspection of the company's manufacturing facility. This inspection is mandatory to ensure the facility's compliance with Current Good Manufacturing Practices (CGMPs) before approval can be granted. The FDA also noted that comments on the proposed prescribing information, carton, and container labeling are reserved until other application deficiencies are resolved, advising adherence to specific formatting guidelines like the Selected Requirements for Prescribing Information (SRPI) and Structured Product Labeling (SPL) format upon resubmission. Furthermore, a comprehensive safety update is required, incorporating all nonclinical and clinical study data, detailing significant safety profile changes, and providing retabulated adverse event frequencies and case reports for serious events. The previously conditionally acceptable proprietary name must be resubmitted once all application deficiencies are addressed. Milestone Pharmaceuticals is required to fully address these deficiencies and resubmit the application within one year, as per regulatory requirements under 21 CFR 314.110. The company may also request a meeting with the FDA to discuss the necessary steps for approval. The product cannot be legally marketed until written approval is issued.