Determination of Regulatory Review Period for Purposes of Patent Extension; VITREON; Amendment

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The Food and Drug Administration (FDA) is amending its determination regarding the regulatory review period for purposes of patent extension for VITREON that appeared in the Federal Register of December 17, 1998 (63 FR 69633). FDA is amending the document because the agency agrees with the information provided in a request from the applicant for revision of the regulatory review period.