Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836

Özet

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