Teva and MedinCell get CRL for TV-46000/mdc-IRM NDA

20 April 2022

The US subsidiary of Teva Pharmaceutical Industries (NYSE: TEVA) and MedinCell (Euronext: MEDCL) announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.

Teva and MedinCell remain committed to the development of risperidone and to providing patients with access to the product in the USA, as quickly as possible. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations.

MedinCell’s shares plunged nearly 25% to 6.63 euros by late morning trading today, while Teva’s stock was down 4.9% at $10.18 pre-market.

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