Thursday - May 22, 2025
FDA Determines Regulatory Review Period for ELREXFIO for Patent Extension
May 10, 2025
WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has announced its determination regarding the regulatory review period for the human biological product ELREXFIO, which is developed by Pfizer Inc.

The announcement comes after a request by the U.S. Patent and Trademark Office (USPTO) for FDA's assistance in determining the regulatory review period for patent term restoration related to this product. The review per . . .

Targeted News Service Document Request Form

This document is available to you by e-mail if you complete the form below with relevant information. There may be a fee for this article or ongoing service of similar materials. We will be in touch shortly.

Name:
What's your
Affiliation
Government Newspaper / Media Business
Public Policy Individual / Student Educators
Email:
Phone:
Organization, if any:
State/Country you are in:
Additonal questions
or comments:

Click here for more information about our products

Click here for more information about our products