Notice 26 Aug 2025 regulatory compliance, fda, pharmaceutical industry, drug approval, patent extension, voranigo

💊FDA Regulatory Review Period Determination for VORANIGO

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

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