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2005P-0458
CP 1
Volume 1

Citizen Petition

Tab 1 - Letter from David Hilfiker to Beckloff Associates, Inc. (April 9, 2003)

Tab 2 - Letter from Curtis Rosebraugh, M.D., M.P.H., to Medi-Flex, Inc. (Nov. 5, 2004) (with related faxes)

Tab 3 - Letter from Michael L. Groesbeck to Gary Buehler (Nov. 18, 2004)

Tab 4 - Letter from Daniel E. Troy to Andrew G. Rozycki (Sept. 19, 2005)

Tab 5 - Letter from Robert P. Giacalone to Medi-Flex Hospital Products, Inc. (Oct. 6, 2005)

Tab 6 - Zeneca Inc. v. Shalala, 1999 U.S. Dist. LEXIS 12327 (D. Md. 1999), aff’d on other grounds, 213 F.3d 161 (4th Cir. 2000)

Tab 7 - Memorandum of Meeting Minutes for June 11, 2003 Meeting between Medi-Flex and FDA (July 2, 2003) at 4

Tab 8 - Letter from Steven K. Galson, M.D., M.P.H., to Donald O. Beers and William F. Cavanaugh, Jr., Docket No. 2004P-0386/CP 1 & RC 1 (Nov. 30, 2004)

Tab 9 - Marion Merrell Dow, Inc. v. Hoechst-Roussel Pharms., Inc., Civ. No 93-5074, 1994 U.S. Dist. LEXIS 10024, 32 U.S.P.Q. 2d 1156 (D.N.J. 1994) (prohibiting a 505(b)(2) applicant for an extended release drug from circumventing patents by relying on the immediate release listed drug instead of the more appropriate extended release listed drug)


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