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…Hatch-Waxman Amendments with respect to Teva Pharmaceutical USA, Inc.’s ANDA for a generic version of Eli Lilly and Co.’s (“Lilliy’s”) EVISTA (raloxifene HCL) Tablets. Under the FDC Act, an NDA…
…Appeals for the Eighth Circuit held that the Relator’s qui tam allegations concerning Defendant’s alleged failure to submit FDA-required medical device reports (“MDRs”) for defective blood glucose monitors was insufficient…
…that a dispute must be “definite and concrete” and “real and substantial” to support the exercise of a district court’s subject matter jurisdiction, and the Federal Circuit’s March 2007 decision…
…Superior Court’s non-precedential decision relied on federal preemption principles to affirm the trial court’s dismissal of Appellant’s second amended complaint with prejudice. Appellant brought wrongful death and survival claims individually…
…by Teva – whether the FDA’s interpretation of subsection (bb)(CC) of the MMA is arbitrary and capricious under the APA – is purely a legal question fit for judicial review. …
…to obtain timely tentative (final) approval forfeiture provision. As initially submitted, Zydus ANDA 091640 contained, among other things, the results of a clinical endpoint bioequivalence study. But just 8 months…
…of approval. At approval, the sponsor of a drug which was designated on the basis of a plausible hypothesis of clinical superiority must demonstrate that its drug is clinically superior…
…years went by without an FDA approval action on the ANDA. Finally, FDA tentatively approved ANDA 090141on March 10, 2017, and granted final approval on May 22, 2018 (just one…
…trial court. The agency believes that the trial court should make determinations of cooperation on a case-by-case basis.” FDA also commented, without qualification, that “[u]nder the statute, the reduction or…
…that after taking Mutual’s Sulindac Tablets in December 2004, Mrs. Bartlett was diagnosed with Stevens-Johnson syndrome progressing to toxic epidermal necrolysis (a serious and potentially fatal condition), and allege that…
Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking…
…constitutes an artificial act of patent infringement which immediately subjects to the ANDA to the risk of costly patent litigation. 35 U.S.C. § 271(a)(2); see also Teva Pharms. USA, Inc….
…that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.) These two videos, which both began with a voiceover that…
…PSGs to include additional bioequivalence studies or evidence recommended to support FDA approval. “Minor Revisions” are any revisions not considered major, including the removal of certain studies, providing alternative and…
…are reserved for egregious, repeated, and intentional criminality. A recent indictment against two former executives, however, may signal the government is making good on its threat even when the conduct…