ROVI informs on the evaluation process to obtain marketing authorisation for Risvan®

Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults


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.
Average: 3.7 (3 votes)
 
Related
Madrid, 4 de marzo de 2022 - Laboratorios Farmacéuticos Rovi, S.A. was certified carbon neutral in 2021 for the second year running....
3 min
04/03/2022
ROVI REPORTS OPERATING REVENUE GROWTH OF 54% AND NET PROFIT GROWTH OF 151% Operating revenue increased by 54% to 648.7 million euros...
2 min
23/02/2022
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Laboratorios...
2 min
16/02/2022