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…are owed by those facility owners are timely paid, because the penalties from appearing on the arrears list (the current version is posted here) [http://www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm] flow downstream to the the…
…Commonwealth from taking any action to implement or enforce the declaration and order. Though down, the Commonwealth was not out. Commonwealth officials went right to work after the district court’s…
…a product marketed as a dietary supplement; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hua-da-trading-inc-664359-12202023); Botanical Be of El Paso, Texas (“Kuka Flex Forte” and “Reumo Flex,” marketed as dietary supplements, contain diclofenac; Warning Letter; and com,…
…recognized that compliance with postmarketing submission requirements poses unique difficulty for “real time” communications (e.g., blog posts, comments on a website, and twitter feeds), namely, the requirement that the firm…
…civil inquiry and demand from the [Federal Trade Commission (“FTC”)]. The FTC requested documents and other information relating to requests by generic companies to purchase our patented REVLIMID® and THALOMID®…
…is the latest in a recent spat of cases concerning Hatch-Waxman issues, including controversies over generic PLAVIX (clopidogrel bilsulfate), generic DEPAKOTE (divalproex sodium), and generic RISPERDAL (risperidone) Tablets. By Kurt…
…argues that “the district court improperly refused to exercise jurisdiction over Nu-Pharm’s complaint” when it declined to exercise subject matter jurisdiction over Nu-Pharm’s complaint for “prudential reasons” given the order…
…Blog, labeling carve-out issues and controversies will likely continue to arise in the forseeable future as brand-name companies take aim at would-be generic competitors. As we previously reported, on December…
…alleged in their opposition papers (here and here) that the lawsuit was merely a last-ditch effort by Prometheus to delay generic LOTRONEX competition. Thus, for example, FDA alleges that: after…
…current prescription and Over-the-Counter drug (“OTC“) classes – insofar as there would be no expectation that BTC drugs would eventually switch to the prescription or OTC class. The second view is…
…United States, FDA requires proof that the product: (1) was marketed outside the United States as an ingredient in OTC drugs for purchase by consumers; and (2) was “marketed OTC…
…for a material time under such conditions.” See Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 631 (1973); Premo Pharmaceutical Labs., Inc. v. United States, 629 F.2d 795,…
…content” rather than the aforementioned “prohibited content.” Facebook’s restricted content policy for OTC drugs requires that the branded content “must comply with all applicable local laws, required or established industry…
…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…
…Brief Teva’s Reply Brief REMINDER: Register for HPM’s free webinar “The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine” on October 8th. (link to registration: http://hpmwebinar.eventbrite.com/)…