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ROVI informs on the evaluation process to obtain marketing authorisation for Risvan®
- The United States Food and Drug Administration (FDA) has issued a Complete Response Letter. In this letter, the FDA informs ROVI that it considers the responses to the evaluation of the Risvan® dossier to be complete and makes no additional observations.
- The letter states that ROVI must close the observations made by the FDA during its inspection in May 2023. ROVI will submit a response to reinitiate the procedure providing details of the responses that have already been filed. ROVI will then await a further notification from the FDA with the estimated User Fee Goal Date for the closure of the procedure, which is expected to be in February 2024.
- There are no observations that have not yet been resolved by ROVI's suppliers.
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