FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION OF REGULATORY REVIEW PERIOD FOR PURPOSES OF PATENT EXTENSION; LAMZEDE

WASHINGTON, May 12 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE.

The notice was published in the Federal Register on May 12 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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.

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