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MedinCell’s Partner Teva Today Announced Refiling for Approval of mdc-IRM and Confirmed Planned Launch in the U.S. in H1 2023

MONTPELLIER, France--(BUSINESS WIRE)--MedinCell’s (Paris:MEDCL) partner, Teva, today announced that it recently completed the re-submission to a New Drug Application to the U.S. FDA for mdc-IRM, a risperidone subcutaneous Long-Acting Injectable (LAI) 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 c
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