Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ; Correction and Reopening of the Comment Period

Zusammenfassung

The Food and Drug Administration (FDA) is correcting notices concerning FDA's determination of the regulatory review period for PRISTIQ that appeared in the Federal Registers of August 31, 2010 (75 FR 53314) and September 2, 2010 (75 FR 53969). The documents omitted docket number FDA-2009-E-0086. This document corrects those omissions. Because the comment period for the notices closed on February 28, 2011, FDA is reopening the comment period to allow interested parties to submit comments or petitions to docket number FDA-2009-E-0086.