← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEDecember 8, 2023NOTICE — NO LEGAL EFFECT

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

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEFeb 6, 2024 · closed
APPLIES TO · SPEQ TAGDrug
Document type
Notice
Agency
Health and Human Services Department
Published
December 8, 2023
Comments close
February 6, 2024
Document number
2023-27003
Docket
FDA-2019-E-5256
ABSTRACT

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SEYSARA 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.

Abstract as published in the Federal Register.

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