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…for the same disease for seven years once it approves an orphan drug for marketing. Eagle Pharms., Inc. v. Azar, 18-5207, 15 (D.C. Cir. 2020). As the court explained, by…
…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…
…monthly AMP, manufacturers must use a 12-month rolling average to estimate lagged price concessions (e.g., chargebacks and rebates) (pages 388-89). The 12-month rolling period should include the reporting month (page…
…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,…
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…
…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…
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…
…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…
…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….
…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…
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…
…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….
…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…
…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…
…exclusivity expires on September 23, 2007. Mylan’s arguments hew closely to those the company made in its Emergency Application. On March 21, 2007, Pfizer submitted two petitions (Docket Nos. 2007P-0110…