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

摘要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 17, 2003 (68 FR 18992). The document announced that FDA had determined the regulatory review period for FASLODEX. A request for revision of regulatory review period was filed for the product on June 16, 2003. FDA reviewed its records and found that the effective date of the investigational new drug application (IND) was incorrect due to a clerical error. Therefore, FDA is revising the determination of the regulatory review period to reflect the correct effective date for the IND.