Redetermination of Regulatory Review Period for Purposes of Patent Extension; BONIVA; Correction

概要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 22, 2006 (71 FR 35918). The document announced that FDA had determined the regulatory review period for BONIVA. The notice provided that on or before August 21, 2006, anyone with knowledge that any of the dates as published are incorrect may submit a request for a redetermination of the regulatory review period. A request for revision of the regulatory review period was filed for the product on July 25, 2006. FDA reviewed its records and found that the effective date of the investigational new drug application (IND) was incorrect because of a clerical error. Therefore, FDA is republishing a determination of the regulatory review period to reflect the corrected effective date for the IND. FDA has made a determination of the regulatory review period 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.