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

Zusammenfassung

The Food and Drug Administration (FDA) is correcting the notice that appeared in the Federal Register of August 30, 1994 (59 FR 44737). The document announced FDA's determination of the regulatory review period for purposes of patent extension for Neutrexin TM (trimetrexate glucuronate). The document was published with an error in one of the dates stated as part of the regulatory review period and requires additional clarification between the patent extension applicant's records and FDA's records.