Determination of regulatory review period for purposes of patent extension; Lusedra.

The US Food and Drug Administration (FDA) has determined the regulatory review period for Lusedra and is publishing this notice of that determination as required by law. The FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, US Department of Commerce, for the extension of a patent which claims that human drug product. The FDA approved for marketing the human drug product Lusedra (fospropofol disodium), which is a sedative-hypnotic agent indicated for monitored anaesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures. Subsequent to this approval, the Patent and Trademark Office received …