Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

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The Food and Drug Administration (FDA) has determined the regulatory review period for VIMPAT based on new drug application (NDA) 22-253 for VIMPAT TABLETS 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 Patents and Trademarks, Department of Commerce, for the extensions of patents which claim the human drug product, VIMPAT. The regulatory review period determination for VIMPAT Injection is publishing in this issue of the Federal Register.