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…either party to the action failed to reasonably cooperate in expediting the action . . . .” FDC Act § 505(j)(5)(B)(iii) (emphasis added). Since the enactment of the Hatch-Waxman Amendments…
…spare you all of the details of the case. Instead, we will focus on FDA’s Letter Decision. But first, some quick facts . . . . Hi-Tech submitted the first…
…patent.” Teva’s complaint and motion for preliminary injunction requests that the court enter an injunction compelling FDA to relist the ‘952 patent and restore the company’s Paragraph IV certification, declare…
…to liability under the AKS. In the second case before Judge Zobel, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ), defendant Omnicare filed a 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…
…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…
…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…
…Agency . . . no longer recommends comparative clinical endpoint studies to show bioequivalence for these products. Rather, . . . applicants should show bioequivalence to certain NDAs for mesalamine…
…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…
…‘underlying NDA’ only if the subsequent 505(b)(2) applicant specifically relied for approval on the drug product approved in the underlying NDA. . . .” (italics in original; bold italics added)….
…the generic applicant for patent infringement. Not surprisingly, both this Court and the D.C. Circuit agreed with that commonsense position. See, e.g., TorPharm, Inc. v. Thompson, 260 F. Supp. 2d…
…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) . . ….
…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…
…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….
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)…