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…compete with generic competitors who (especially if Defendants prevail on the basis that patent claims are invalid) would not have borne the competitive burden of the litigation expense. This is…
…Amneal forfeited eligibility for 180-day exclusivity for generic versions of NAMENDA XR (memantine HCl) Extended-release Capsules, 7 mg, 14 mg, 21 mg, and 28 mg. As such, Amneal seeks declaratory…
…make preparations to comply with the rule. FDA also proposes a staggered compliance date to allow blood and blood components more time for compliance. Comments on the proposal are due…
…concerning preemption: We have determined that the rule will have a preemptive effect on State law. Section 4(a) of [Executive Order 13132] requires agencies to “construe . . . a Federal…
…Court involving the scope and powers of the Federal Trade Commission’s Bureau of Consumer Protection relating to deceptive practices. The Court’s decision in AMG will likely come down sometime between…
…of the order, FDA defines PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an IV [Iodine Value] greater than…
…Columbia issued a 2-page order siding with Teva. The order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to relist the patent in the Orange Book…
…CVS/Pharmacy Nos. 219 and 5195; Decision and Order, 67 Fed. Reg. 62315 (Oct. 12, 2012). Noticeably absent from the resolutions are any indication that the AMA will urge its physician…
…the Federal Trade Commission (see here). As noted above, the CREATES Act addresses both ends of the generic drug (and biological product) spectrum: the availability of reference product sample needed…
…Medical Device User Fee and Modernization Act (“MDUFMA”). According to press reports (see here), FDA and industry are still haggling over some issues. The House Energy and Commerce Committee has…
…prohibited the generic product from being distributed. Mylan and Metrics intervened as parties in the litigation. ISTA failed to secure a TRO, and filed an Amended Complaint that added allegations…
…Plaintiffs’ theory, wrote Judge Shoob: Mylan would have had two avenues for changing the label on the generic 100-mg phenytoin: (1) after Mylan changed the 300-mg label, Mylan would have…
…to FDA challenging the Agency’s draft bioequivalence recommendation for generic VANCOCIN, which provides that bioequivalence may be established based on comparative dissolution (i.e., in vitro information). Last Friday we got…
…of fidelity to Congress’s enactments. As a result, FDA finds itself whipsawed, with a ‘damned-if-you-do, damned-if-you-don’t’ dilemma in administering this very complex statute,” according to FDA. UPDATE (April 6, 2010):…
…biosimilars, or the corollary for biologics of generic competition for small-molecule drugs. 2012 is shaping up to be an exciting year, indeed! ADDITIONAL READING: Generic Pharmaceutical Association Press Release …