The Food and Drug Administration (FDA) has announced the regulatory review period for NEXOBRID, a product used for eschar removal in adults with certain types of burns. This review period is relevant to an application for patent term extension submitted to the U.S. Patent and Trademark Office (USPTO) by MediWound, Ltd. The FDA determined that the total regulatory review period for NEXOBRID was 7,427 days, with a request for a 5-year patent extension being made. The public can submit comments on this determination until February 28, 2025, and may petition the FDA to review whether the applicant acted with due diligence during this period by June 30, 2025.
Simple Explanation
The FDA decided how long it took to review a special medicine called NEXOBRID, used to help treat burns, and said it was nearly 20 years. They gave the company a chance to ask for more time on their patent so they can keep selling it without others copying it.