Teva refiles NDA for schizophrenia treatment

Teva Pharmaceuticals announced it recently completed resubmission of a new drug application to the FDA for mdc-IRM, a risperidone subcutaneous long-acting injectable for the treatment of schizophrenia.

Teva’s treatment for schizophrenia uses proprietary technology from MedinCell, a pharmaceutical company.

According to a release issued by MedinCell, following a complete response letter from the FDA in mid-April, Teva conducted a complete quality check of all clinical data.

MedinCell was notified by Teva in September that initiation of phase 3 activities for a second LAI antipsychotic using the same technology had commenced, per the release. This phase will assess the efficacy and safety of the first subcutaneous LAI formulation of olanzapine for the treatment of those with schizophrenia.

Teva expects FDA review and approval to take up to 6 months post-resubmission. The company hopes to launch the therapeutic under the brand name Uzedy in the first half of 2023, the release stated.