> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Rejects Teva/MedinCell Risperidone NDA
- URL: https://www.fdaweb.com/fda-rejects-teva-medincell-risperidone-nda/
- Published: 2022-04-20T12:00:00.000Z
- Updated: 2026-09-14T17:41:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151641

FDA has issued Teva Pharmaceuticals and MedinCell a complete response letter on their NDA for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for treating schizophrenia. Without disclosing the reason for the rejection letter, the companies say they remain committed to developing the product and “will work closely with FDA to address their recommendations.”

The submission includes Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia). “These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia,” the companies say.

Risperidone, an atypical antipsychotic, was first approved by FDA in 1993 and marketed by Janssen Pharmaceuticals as Risperdal.