Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE; Correction

摘要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 2, 2007 (72 FR 15699). The document concerned FDA's determination of the regulatory review period for KEPIVANCE. The document cited an incorrect statute under which the KEPIVANCE biologics license application was submitted. This document corrects the citation.