FDA CRL - Laboratorios Farmaceuticos Rovi S.A.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Laboratorios Farmaceuticos Rovi, S.A. for their New Drug Application (NDA 214835) for Risvan (risperidone ISM) intramuscular injectable suspension. The FDA determined that the application cannot be approved in its current form due to several deficiencies under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Key issues include an inadequate Drug Master File (DMF) for the sterile drug substance risperidone and unresolved deficiencies found during recent inspections of the manufacturing facility. Microbiological concerns were raised regarding the validation studies for solvent DMSO and sterile excipient PLGA, requiring additional data and investigations into past revalidation issues. Human factors identified a vulnerability in the Instructions for Use (IFU) related to medication viscosity, which could lead to injection errors. The FDA requires the IFU to explicitly instruct users to inject the medication slowly and steadily. Other required actions include updating prescribing information, adding a specific statement to carton and container labeling, resubmitting the proprietary name upon addressing all deficiencies, and providing a comprehensive safety update detailing any significant changes in the product’s safety profile, with combined and comparative adverse event data. Resolution of all identified deficiencies is mandatory for potential approval.