FDA CRL - Cadence Pharmaceuticals

This FDA Complete Response Letter (CRL), dated February 10, 2010, informs Cadence Pharmaceuticals that its New Drug Application (NDA 022450) for Ofirmev (acetaminophen) Injection cannot be approved in its current state. The primary reason for non-approval stems from a recent inspection of the Baxter Healthcare manufacturing facility in Cleveland, MS, where the FDA identified deficiencies. Compliance with Current Good Manufacturing Practices (cGMP) for drugs is a mandatory prerequisite for all facilities listed in the NDA before approval can be granted. The regulatory framework for this application is under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Additionally, the FDA requires a comprehensive safety update, in line with regulatory stipulations for New Drug Applications. This update must detail any significant changes in the drug's safety profile, present new clinical trial data combined with existing NDA data, compare adverse event frequencies, and include case report forms and narrative summaries for all patient deaths or trial discontinuations due to adverse events. Updated exposure information and a summary of worldwide safety experience, with translations of foreign labeling, are also required. Comments on the proposed labeling are reserved until these other issues are adequately addressed. Cadence Pharmaceuticals must address all identified deficiencies and resubmit the application within one year, as partial responses will not initiate a new review cycle. The drug cannot be legally marketed until written approval is received.