Laboratorios Farmaceuticos Rovi S A : ROVI informs on the evaluation process to obtain marketing authorisation for Risvan®
July 28, 2023 at 03:31 am EDT
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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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Laboratorios Farmacéuticos ROVI SA published this content on 28 July 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 July 2023 07:30:07 UTC.
Laboratorios Farmaceuticos Rovi, S.A. specializes in the research, development, manufacturing and marketing of biological medications and specialty drugs. Net sales break down by family of products as follows:
- pharmaceutical products manufactured under contract (49%);
- prescription pharmaceuticals (45%): intended for preventing and treating venous thrombo-embolic disease, post-menopausal osteoporosis, muscle pain, tooth and mouth infections, angina, osteoarthritis, etc.;
- diagnostic products (6%): contrast products used in medical imaging with magnetic resonance, ultrasound, or X-rays. The group also offers hospital products and non-prescription pharmaceuticals.
Net sales break down by source of revenue between sales of products (50.6%), sales of services (49.3%) and sales of licenses (0.1%).
Net sales are distributed geographically as follows: Spain (33%), European Union (17.3%), OECD countries (45.9%) and other (3.8%).
LABORATORIOS FARMACEUTICOS ROVI, S.A. 
