Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK TABLETS, New Drug Application 212725

요약

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROZLYTREK TABLETS new drug application (NDA) 212725 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 claim that human drug product.