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Product safetyFDAUnited StatesImports

Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY

9 September 2026

In plain English

FDA has determined the regulatory review period for ANDEMBRY following a patent extension application to the USPTO, as required by law.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
9 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

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