Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

Summary

The Food and Drug Administration (FDA) has determined the regulatory review period for VIMPAT injection, a new drug application (NDA 22-254), and is publishing this notice as required by law. The determination is due to patent extension applications submitted to the Director of Patents and Trademarks, Department of Commerce, for the human drug product VIMPAT.