💊FDA's Determination of Regulatory Review Period for RIVFLOZA
Determination of Regulatory Review Period for Purposes of Patent Extension; RIVFLOZA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RIVFLOZA 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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulation involves the FDA's determination of the regulatory review period for RIVFLOZA and its implications for patent extension, which impact market exclusivity and potential revenues for related businesses. Compliance with filing requirements and deadlines for patent extensions is crucial for business owners and executives in the pharmaceutical industry.