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💊FDA Notice on Regulatory Review Period for XOLREMDI Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XOLREMDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.