Teva Resubmits NDA for Long-Acting Schizophrenia Drug Candidate

Teva resubmitted a New Drug Application (NDA) to the FDA for mdc-IRM, a risperidone subcutaneous long-acting injectable for maintenance treatment of schizophrenia, following a Complete Response Letter (CRL) the company received from the FDA in April.

The drug is the result of a partnership with MedinCell and uses that company’s proprietary technology. While neither company disclosed the contents of the CRL, MedinCell said that following the CRL, “Teva worked quickly to align on a path forward and to conduct a complete quality check of all clinical data.”

The companies are also in partnership to develop a subcutaneous long-acting injectable formulation of olanzapine for the treatment of patients with schizophrenia.

MedinCell is eligible to receive development and commercial milestone payments up to $122 million.