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…was most famously the topic of the U.S. Supreme Court’s decision in Caraco Pharm. Labs, Ltd. v. Novo Nordisk A/S, __ U.S. __; 132 S. Ct. 1670 (2012) (see our…
…the action.” 21 U.S.C. § 355(j)(5)(B)(iii). The Federal Circuit has made it clear [in Eli Lilly & Co. v. Teva Pharm. USA, Inc., 557 F.3d 1346 (Fed. Cir. 2009) and…
…despite being in earlier drafts of the SDCA. See FDASIA, Pub. L. No. 112-144, § 1152 (2012); 77 Fed. Reg. 64032 (Oct. 18, 2012); H.R. 1254 112th Cong. (2012). See…
…retailer QVC, Inc. The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision and order in which the Commission ordered QVC to cease representing certain products…
…or animals. FDA must first give the responsible party an opportunity to conduct a voluntary recall. If the responsible party refuses to do so, and the Commissioner issues an order,…
…to current good manufacturing practices (“cGMP”) while using components that are shipped in interstate commerce. FDA v. Regenerative Sciences, LLC et. al., Untied States District Court for the District of…
…appeal is coming . . . and we’ll let you know if that happens. But FDA’s track record in these types of APA challenges does not bode well for Sanofi….
By Kurt R. Karst – Earlier this week, Rep. Jan Schakowsky (D-IL), along with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced H.R. 5786, the Safe Cosmetics Act…
…other health benefit of such product unless the representation is not misleading and is adequately substantiated. The modified order now describes FTC’s substantiation standard in detail. Kellogg must have: competent…
…time is received on the same calendar day. . . . Second, the FDA was conducting business after 4:30 p.m. on December 15,2000, and any other time it takes action….
…committee dedicated to the review of ETASU. In the interim, Kaiser suggests that advisory committees (with a health care provider member) reviewing drugs that will likely receive ETASU also have…
By Kurt R. Karst – Earlier this week, Astellas Pharma US, Inc. (“Astellas”) filed a Complaint and an accompanying Memorandum of Points and Authorities in the U.S. District Court for the District…
On January 14, 2008, Nu-Pharm Inc., a Canadian drug company formerly owned by Apotex, Inc., filed a complaint in the U.S. District Court for the District of Columbia against FDA…
…Extended Release Tablets, 4mg and 2mg. (The other patents are U.S. Patent Nos. 5,382,600 (“the ’600 patent”), 6,630,162 (“the ‘162 patent”), and 6,770,295 (“the ‘295 patent”), which expire on March…
…accompanying memorandum, the company states “[n]ow that the FDA has delisted the Pfizer patent, Mylan’s claim to 180-day exclusivity has moved to the forefront. . . . Mylan is likely…