<searchTitle>Determination of Regulatory Review Period for Purposes of Patent Extension; Vyndamax; Federal Register Vol. 89, Issue </searchTitle>
<granuleClass>NOTICE</granuleClass>
<accessId>2024-24187</accessId>
<agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
<agency order="2">Food and Drug Administration</agency>
<commentDate>2024-12-20</commentDate>
<departmentDoc>Docket No. FDA-2022-E-3123</departmentDoc>
<billingCode>4164-01-P</billingCode>
<frDocNumber>2024-24187</frDocNumber>
<action>Notice.</action>
<summary>The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYNDAMAX 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.</summary>
<dates>Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by December 20, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 21, 2025. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.</dates>
<contact>Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.</contact>
<tocSubject1>Patent Extension Regulatory Review Period</tocSubject1>
<tocDoc>Vyndamax, </tocDoc>
<urlRef>https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</urlRef>
<urlRef>https://www.regulations.gov</urlRef>