The Food and Drug Administration (FDA) has determined the regulatory review period for FYCOMPA 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 a patent which claims that human drug product.
Document
Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA
The Food and Drug Administration (FDA) has determined the regulatory review period for FYCOMPA and is publishing this notice of that determination as required by law. FDA has ma...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
81 FR 65655
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA,” thefederalregister.org (September 23, 2016), https://thefederalregister.org/documents/2016-22933/determination-of-regulatory-review-period-for-purposes-of-patent-extension-fycompa.