FDA CRL - Otsuka Pharmaceutical Company, Ltd.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Otsuka Pharmaceutical Company, Ltd. on July 26, 2012, regarding the New Drug Application (NDA 202971) for ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.110, the FDA determined the application could not be approved in its current form due to specific regulatory hurdles. The primary issues identified involve manufacturing facility deficiencies discovered during a recent inspection. The FDA requires these facility-related concerns to be resolved satisfactorily before approval. Additionally, the applicant must submit final printed carton and container labels and updated content of labeling in the Structured Product Labeling (SPL) format, as previously discussed in July 2012. To move forward, Otsuka Pharmaceutical must take action within one year of the letter's date. This includes a full resubmission addressing all identified deficiencies or requesting a meeting with the FDA to discuss necessary steps for approval. Failure to respond within this timeframe may result in the withdrawal of the application. The drug product cannot be legally marketed in the United States until written approval is granted.