FDA accepts NDA for Teva and MedinCell's schizophrenia candidate

1 September 2021

Teva Pharmaceutical Industries (NYSE: TEVA) and its partner MedinCell (Euronext: MEDCL) have announced that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for schizophrenia has been accepted by the US Food and Drug Administration (FDA).

Following the announcement on Tuesday evening, shares in Israeli drugmaker were up 1% in Wednesday’s pre-market trading in New York, while France-based MedinCell was trading 5% higher by lunchtime in Europe.

"NDA file acceptance marks a major milestone for MedinCell"The acceptance is based on Phase III data from two pivotal studies, results from which have not yet been shared. These trials evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.

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