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…Labs. Ltd., No. 08 C 0953, 2009 U.S. Dist. LEXIS 126929 (E.D. Wis. Sept. 24, 2009)), the North Carolina District Court denied Sandoz’s Motion to Dismiss. The Court concluded that…
…in their Oppositions briefs (here and here). They cite Abbott Labs. v. Teva Pharms. USA, Inc., 432 F. Supp. 2d 408 (D. Del. 2006), which is referred to as “TriCor,”…
…Inc., __ U.S. __, 133 S. Ct. 2223 (June 17, 2013), which dealt with drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) and the appropriate antitrust analysis…
By Kurt R. Karst – In a rather lengthy (33-page) response to two citizen petitions submitted to FDA by AbbVie Inc. (Docket No. FDA-2011-P-0610) and Auxilium Pharmaceuticals, Inc. (Docket No. FDA-2013-P-0371)…
…GRASE. FDA proposes to allow ingredients deferred from the final rulemaking to remain on the market as the data are being generated. Comments must be submitted by May 27, 2019….
…Inc. v. Louisiana Wholesale Drug Company, Inc. (Docket Nos. 12-245) and Upsher-Smith Laboratories, Inc. v. Louisiana Wholesale Drug Company, Inc. (Docket No. 12-265) concerning K-DUR (potassium chloride), seems to have…
…Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). But the proposals never gained traction in Congress (at least not in the form of a legislative proposal) . . ….
…mg, 10 mg, and 20 mg strengths but approximately six months before the 30-month forfeiture date of April 14, 2011 for the 2.5 mg strength. . . . FDA generally…
…Pharms., USA, 620 F. Supp. 2d 899 (N.D. Ill. 2009), Kellogg v. Wyeth, 612 F. Supp. 2d 421 (D. Vt. 2008), Schrock v. Wyeth, Inc., 601 F. Supp. 2d 1262…
…at 7 (citing FDC Act § 310(a)). Citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001) (“State-law fraud-on-the-FDA claims inevitably conflict with the FDA’s responsibility to police…
…Agency . . . no longer recommends comparative clinical endpoint studies to show bioequivalence for these products. Rather, . . . applicants should show bioequivalence to certain NDAs for mesalamine…
…complied and submitted the ANDA amendment. In November 2006, the U.S. Court of Appeals for the District of Columbia decided in Ranbaxy Laboratories Ltd. v. Leavitt that FDA may not…
…by PLIVA, Inc., Teva Pharmaceuticals USA, Inc., and UDL Laboratories, Inc. The second Petition is docketed as Docket No. 09-1039 and was filed by Actavis Elizabeth, LLC. Opposition and reply…
…USA. The conference will be held in Washington, D.C. from April 12-15. Hyman, Phelps & McNamara, P.C. is an associate sponsor of the conference. Additional information on the conference is…
…30th anniversary as well . . . . and here on the FDA Law Blog in our own special way. For several years now we have taken stock of the…