FDA CRL - IPR Pharmaceuticals, Inc.

OWP Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 218879) for lamotrigine oral suspension. The FDA determined the application cannot be approved in its current form due to several outstanding issues. A primary concern is that the proposed drug substance manufacturing facility is not yet operational, necessitating a satisfactory inspection before approval. The company must confirm the facility is ready for inspection as part of its response. Additionally, the FDA requires a comprehensive safety update, encompassing detailed analysis of safety profile changes, new clinical trial data, combined safety data tabulations, comparisons of adverse event frequencies, and worldwide safety experience. The submission must also include case report forms and narrative summaries for deaths or trial discontinuations due to adverse events. Further actions include revising the proposed prescribing information to conform with regulatory standards, addressing specific comments on carton and container labeling, and resubmitting the proprietary name once all other deficiencies are resolved. OWP Pharmaceuticals, Inc. has one year to resubmit a complete response, clearly marked as such, or risk withdrawal of the application. The product cannot be legally marketed until written approval is granted.