FDA CRL - NeuroScience, Inc.

Teva Neuroscience, Inc. received a Complete Response Letter (CRL) from the FDA for New Drug Application (NDA) 213586, concerning risperidone extended-release injectable suspension. The FDA identified significant data quality issues within pivotal clinical studies (TV-46000-CNS-30072 and TV-46000-CNS-30078). Key violations included investigational product (IP) dosing errors, insufficient documentation of IP administration, and instances of multiple patient enrollments. These deficiencies rendered the dosing data unreliable, preventing the FDA from verifying product efficacy, establishing an effective dose range, or evaluating the exposure-response relationship for safety. Consequently, the application lacks adequate evidence for an efficacy finding. To resolve these clinical issues, Teva must either submit results of an independent third-party audit covering all study sites and subjects, along with updated analyses, or conduct a new, well-controlled clinical efficacy and safety study. Additionally, the FDA cited deficiencies in the proposed prescribing information and carton/container labeling. Required actions include submitting a stand-alone Instructions for Use document, revising primary strength statements to include volume, adding "Rx Only" and route of administration to syringe labels, specifying expiration date formats, adding dosage statements to cartons, and clarifying the presence of required product identifiers.