← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEMarch 13, 2024NOTICE — NO LEGAL EFFECT

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

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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 CLOSEMay 13, 2024 · closed
APPLIES TO · SPEQ TAGDrug
Document type
Notice
Agency
Health and Human Services Department
Published
March 13, 2024
Comments close
May 13, 2024
Document number
2024-05305
Docket
FDA-2019-E-5660, FDA-2019-E-5661
ABSTRACT

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAURISMO 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 patents which claims that human drug product.

Abstract as published in the Federal Register.

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