Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Application 207501

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The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207501 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 as approved under NDA 207501.