The pharmaceutical company Rovi will have to wait until at least February 2024 to obtain authorization from the US Health Administration (FDA) for the marketing of Risvan, a medicine for the treatment of schizophrenia that in Europe is called Okedi.
The pharmaceutical company expected the procedure to be closed on Thursday, July 27, but the FDA has requested during a Rovi that a response to the observations made by the agency be made to the previous inspection last May before continuing with the authorization process.
Rovi has informed the National Securities Market Commission (CNMV) that it will detail the responses to these observations with the aim of “restarting the procedure” and will wait for the health administration authorities to set a new date for completion of the process. of the authorization.
