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Medincell: towards a new US indication for Uzedy

(CercleFinance.com) - Medincell and its Israeli commercial partner Teva announced last night that the FDA had agreed to consider their request for an extension of the indication for Uzedy, this time for the treatment of patients suffering from bipolar disorder.


The US health agency has accepted the request for an extension of the indication for the treatment of bipolar I disorder in adults for their antipsychotic, proposed in the form of an extended-release subcutaneous injectable suspension.

Uzedy is already approved in the U.S. as a subcutaneous long-acting injectable (LAI), administered once a month or every two months, for the treatment of schizophrenia in adults.

Medincell shares advanced by just over 1% on Wednesday on the Paris Bourse following this news, but are still down more than 20% since the start of the year.

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