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…Eli Wallach as “the Ugly”: the “Prompt Approval of Safe Generic Drugs Act” (H.R. 2831) and the “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of…
…doctor’s application. In the lengthy final order, the Administrator took issue with several of the legal issues addressed by the CALJ, including the following. Interpretation of Oklahoma Medical Board Standards:…
…as guidance: Step 2: Give 1st dose of Narcan OTC Nasal Spray HOLD the Narcan OTC Nasal Spray with your thumb on the bottom of the plunger INSERT the tip…
…order restricting Canadian sellers from distributing drugs outside of Canada. The Executive Order places the Biden Administration firmly behind drug importation. Although the Order is careful to repeat Section 804’s…
…not available to generic drug sponsors, “a generic manufacturer can avoid consumer confusion because, if the FDA accepts the proposed change, that change would be imposed uniformly on both generic…
…for reviewing generic versions of so-called Non-Biologic Comples Drugs (“NBCDs”). A similar request was made earlier this year as part of the “Generic Complex Drugs Safety and Effectiveness for Patients…
…preempt state-law failure-to-warn claims against generic drug manufacturers, because it is impossible for generic drug manufacturers to comply with both federal and state duties to warn. In contrast, in Wyeth,…
…to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because it is impossible for generic drug manufacturers to comply with both federal and…
…the insurer’s generic icosapent ethyl capsules prior authorization form. Thus, the court concludes, “Health Net’s placement of generic icosapent ethyl on a preferred tier encourages the substitution of the generic…
…the identification of facilities involved in the manufacture of generic drugs and associated active pharmaceutical ingredients, and improving FDA’s communications and feedback with industry in order to expedite product access….
…of AG competition against an ANDA generic, not from the presence of AG competition against an ANDA generic. FTC Chairman Jon Leibowitz and Commissioner Rosch issued separate statements on the…
…generic Vancocin Capsules, including: Twenty-four citizen petition filings submitted to the FDA; Seventeen public comments submitted to the FDA regarding the FDA’s in vitro dissolution guidance for generic Vancocin Capsules;…
…its ANDA. The Complaint also alleges that FDA’s decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission…
…Armando allegedly consumed McNeil’s OTC drug Tylenol Cold (and/or Tylenol Flu) containing pseudoephedrine for a head cold, along with a caffeinated beverage, the morning of the roller hockey game. Doctors…
…ages are common on OTC drug labels. As such, Ms. Sebelius’ claim that cognitive differences between older and younger women requires additional label comprehension studies was found to “reflect[] the…