Determination of regulatory review period for purposes of patent extension: Tygacil.

(From Chemical Business NewsBase - Federal Register)

The Food and Drug Administration (FDA) has determined the regulatory review period for TYGACIL 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FDA recently approved for marketing the human drug product TYGACIL (tigecycline). TYGACIL is indicated for the treatment of infections caused by susceptible strains of designated microorganisms in certain conditions. Subsequent to this approval, …