Posted by Michael Wonder on 04 Nov 2022
MedinCell’s partner Teva today announced refiling for approval of mdc-IRM and confirmed planned launch in the US in H1 2023
3 November 2022 - MedinCell’s partner, Teva, today announced that it recently completed the re-submission to a new drug application to the US FDA for mdc-IRM, a risperidone subcutaneous long-acting injectable for the maintenance treatment of schizophrenia using MedinCell’s proprietary technology.
Following a complete response letter from the FDA in mid-April, Teva worked quickly to align on a path forward and to conduct a complete quality check of all clinical data.
