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

The US Food and Drug Administration (FDA) has determined the regulatory review period for Mozobil 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, 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 Mozobil (plerixafor), which is indicated in combination with granulocyte-colony stimulating factor to mobilize haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma …