Laboratorios Farmaceuticos Rovi S A : ROVI informs on the evaluation process to obtain marketing authorisation for Risvan®
February 16, 2023 at 01:19 pm IST
Share
img_7413.jpg
Laboratorios Farmacéuticos ROVI, S.A. (ROVI) informs on the evaluation process to obtain marketing authorisation for Risvan® (Risperidone ISM®) in the United States and reports that it has now filed the final responses to the Complete Response Letter received from the United States Food and Drug Administration (FDA) in the third quarter of 2022. These responses likewise included the answers of one of ROVI's suppliers to outstanding questions.
The FDA has notified ROVI that the user fee goal date is 27 July 2023.
Likewise, ROVI has now filed the final report on correction of the deficiencies noted when the FDA inspected its facilities in June 2022. The evaluation of these corrections, as well as the notification as to whether the FDA will need to reinspect the ROVI facilities, is expected within the period ending on the user fee goal date.
Furthermore, in January 2023, the FDA carried out a pending inspection of a ROVI supplier. As a result of the inspection, the FDA issued a series of observations to said supplier, which the latter is working to answer. The time frame for the supplier's response will depend on how the FDA evaluates the observations issued.
Thus, ROVI is continuing with the roadmap that it notified in the presentation of the update of its strategy at its 2022 Capital Markets Day and will continue to report on the milestones deemed relevant in the process to obtain authorisation of Risvan® from the FDA as the timeline for registration in the United States advances.
Download related document
Select ratingGive ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 1/5Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 2/5Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 3/5Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 4/5Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 5/5
Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 1/5
Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 2/5
Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 3/5
Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 4/5
Give ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® 5/5
Laboratorios Farmacéuticos ROVI SA published this content on 16 February 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 February 2023 07:48:01 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. 
