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