💊Quagen Pharmaceuticals LLC's Application for Controlled Substance Import
Quagen Pharmaceuticals LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Executive Order on Most-Favored-Nation Drug Pricing Impact
Executive Order 14297 aims to rectify the disparity in pharmaceutical pricing between the U.S. and other developed countries. It emphasizes the need for Americans to access drugs at the most-favored-nation prices and outlines immediate policy actions to address foreign pricing disparities. The order also encourages direct-to-consumer sales at these pricing levels, asserting that U.S. patients should benefit from fair drug pricing relative to global standards.
Learn More💊FDA Determines Regulatory Review Period for ADBRY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADBRY 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 biological product.
Learn More💊Wedgewood Pharmacy Seeks Import Registration for Controlled Substances
Wedgewood Pharmacy LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Determination on EPKINLY Patent Extension and Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.
Learn More💊FDA's Patent Extension Determination for OMVOH
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OMVOH 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 biological product.
Learn More💊FDA Determines Regulatory Review Period for LITFULO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LITFULO 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.
Learn More💊FDA Regulatory Review Period Determination for LAMZEDE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE 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 biological product.
Learn More💊FDA Announces Regulatory Review Period for SKYCLARYS Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYCLARYS 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 a patent which claims that human drug product.
Learn More🐾FDA Final Rule on New Animal Drug Regulations Effective May 2025
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
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