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…of submission. Although FDA has previously indicated through at least one approval precedent (see our previous post here) that a tentative approval on the 30-month anniversary date is timely tentative…
By Delia A. Stubbs – The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged…
…hospital or clinic staffing of devices with alarms. All the manufacturer is responsible for is assuring its devices work as intended, including that the alarm operates when it is supposed…
…albeit ones that are undefined – and refused to dismiss Plaintiff’s claim as preempted. In Trazo et al. v. Nestle USA, Inc., Plaintiffs allege that Defendant makes false and misleading…
…blocking 180-day exclusivity altered the ANDA approval equation such that the Agency could approve a subsequent filer’s application. According to FDA’s approval letter, the relinquishment freed things up for Teva:…
…or (bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. The patent delisting counterclaim provision…
…and booking substantial sales revenue.” That almost sounds to us like commercial marketing. And under the statute (FDC Act § 505(j)(5)(b)(iv)(I)), commercial marketing triggering 180-day exclusivity includes “commercial marketing of…
By Kurt R. Karst – For several months now we have been monitoring an appeal to the U.S. Court of Appeals for the Federal Circuit concerning a patent – U.S….
…100 mg, 200 mg, and 400 mg. The Court’s decision also puts the kibosh on FDA’s “bundle of rights” theory, under which an original patent and a reissued patent are…
…FDA and issued a final decision finding that, although Mylan’s, Watson’s, and Lupin’s position that the original exclusivity period had expired was plausible, FDA’s position must be afforded deference. Teva…
…of Appeals for the Federal Circuit affirmed the validy of the patent. Mylan’s subsequent appeal to the U.S. Supreme Court also failed (see here). Thus, Mylan’s Paragraph IV certification to…
…a Tourette’s disorder indication, and that authority is not abrogated or constrained by Section 505A(o). Other Intervenors-Defendants, Alembic Pharmaceuticals Limited, Alembic Limited, Alembic Global Holdings SA and Alembic Pharmaceuticals, Inc., filed…
…render a product “distinct,” and therefore subject to FDA pre-approval. The complaint also alleges that the Final Guidance sets forth final agency positions, imposes legal obligations, establishes consequences for non-compliance,…
…The answer he was looking for was simply “Grant” (and not a numerical figure), although the full correct answer would be Ulysses S. Grant and his widow Julia Dent Grant….
…its “Legal, Medical, Regulatory (LMR) review.” Bayer,slip op. at 11. That review and approval was required for every single piece of promotional material leaving Bayer. Id. Other companies would be…