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

概要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 15, 1994 (59 FR 18133), that announced its determination of the regulatory review period for purposes of patent extension for Mycobutin TM (rifabutin). The document was published with some mathematical errors. The document incorrectly stated, ``FDA has determined that the applicable regulatory review period for Mycobutin TM is 2,831 days. Of this time, 2,124 days occurred during the testing phase of the regulatory review period, while 707 days occurred during the approval phase.'' It should have stated, ``FDA has determined that the applicable regulatory review period for Mycobutin TM is 2,469 days. Of this time, 2,127 days occurred during the testing phase of the regulatory review period, while 342 days occurred during the approval phase.'' This document corrects those errors.