MedinCell provides additional information regarding the new drug application for mdc-IRM

April 20, 2022

 As announced, Teva recently* received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM. 

Christophe Douat, CEO of MedinCell, said “We fully trust that our partner, Teva, will remedy this quickly given the positive results of the Phase 3 studies. Teva remains confident in MedinCell’s technology for the development of extended-release injectable products.” 

A Complete Response Letter is issued when the FDA determines that it cannot approve the application in its current form. Where possible, the FDA will recommend corrective actions that the applicant might take to place the application in condition for approval. 

Dr. Richard Malamut, President of MedinCell’s Medical Advisory Board, said “CRLs are a common part of the FDA regulatory process and resubmission after addressing identified deficiencies frequently leads to approval”. 

Teva remains committed to the development of extended-release injectable risperidone and other products based on MedinCell’s technology. 

*Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM

Session en français

Rendez-vous le mardi 12 septembre à 18h00 pour la diffusion en direct de l'Assemblée Générale mixte

English session

On Tuesday September 12 at 6:00 p.m. live of the Combined General Meeting (in French)

Êtes-vous un actionnaire de MedinCell ? / Are you a MedinCell shareholder?
Vous êtes / You are :
This field is for validation purposes and should be left unchanged.


  • This field is for validation purposes and should be left unchanged.