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…Pharms. USA, Inc. v. Eisai Co., 620 F.3d 1341 (Fed. Cir. 2010), for establishing jurisdiction. LEXAPRO Tablets is currently listed in FDA’s Orange Book with three patents: U.S. Patent Nos….
…It involved Gree Electric Appliances Inc. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co. Ltd., and Gree USA Inc. (the “Gree Companies”), an appliance manufacturer and two of its…
…(mmccorm1@corus.jnj.com), Vice-Chair Freddie K. Park (freddiep99@yahoo.com), or Kurt R. Karst (kkarst@hpm.com) if you are interested in becoming a member of the Special Committee on the FDA and the Hatch-Waxman Subcommittee….
…from the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius. In that case, a 3-judge panel of the D.C. Circuit ruled in a 2-1 decision…
…be consumed on occasion for reasons other than taste, aroma, or nutritive value.”); American Health Products Co., Inc. v. Hayes, 574 F. Supp. 1498, 1507 (S.D.N.Y. 1983), aff’d, 744 F.2d…
…Executive Order on Promoting Competition in the American Economy. The Plan is the Biden Administration’s answer to the Trump HHS’ 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,…
…the lawful order of, a practitioner.” 21 U.S.C. § 802(10). By prohibiting distribution without a valid prescription the Act prohibits something that should not occur. Also, the Act would define…
…close of the proposed regulation comment period. August 18, 2020 has now come and gone with no sign of the proposed rule. In fact, it hasn’t even been added to…
…21 C.F.R. § 1310.05(b)(2), each regulated person must orally report “any domestic regulated transaction in a tableting machine or an encapsulating machine . . . when the order is placed…
…of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities that clearly fall within the…
…other applicant has received tentative approval).” Based on the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, a mere patent delisting request is not enough…
…latest and greatest from ongoing litigation. K-DUR. This long-running litigation involves a challenge by direct purchasers of K-DUR (potassium chloride) Extended-release Tablets who allege that Merck & Co., Inc. (“Merck”)…
…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…
Earlier today, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva. …
…3. The Special Advisory Bulletin concluded that “HHS’s past approach of promoting voluntary compliance has not been fully effective.” Id. at 4. Accordingly, in order to promote increased compliance with…