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…activities undertaken by the ‘applicant’ — the patent owner or its agent, as required by the statute. . . .” (see also Hoechst-Roussel Pharms., Inc. v. Lehman, No. 95-650-A (E.D….
…Circuit’s recent decision in Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), in which the court ruled that Teva did no forfeit 180-day exclusivity eligibility under…
…off is Otsuka Pharmaceutical Co., Ltd.’s (“Otsuka”) two-count Complaint and Motion for Summary Judgment filed against FDA in the U.S. District Court for the District of Maryland concerning ABILIFY (aripiprazole). …
By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst – We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc….
…Capsules, 20 mg and 40 mg. But it wasn’t Ranbaxy Laboratories, Ltd./Ranbaxy, Inc. (“Ranbaxy”) that scored the approval for its long-pending application (ANDA 077830); it was Teva Pharmaceuticals USA subsidiary…
…to come up – and may for years to come. TEVA Pharmaceuticals USA, Inc. (“Teva”) was the first company to submit an ANDA (ANDA 076898) for generic CELEBREX containing Paragraph…
…that “the alleged action taken (giving rise to the injury-in-fact) [is] [the] listing [of] particular patents in the Orange Book.” Teva Pharms., USA, Inc. v. Eisai Co. Ltd., 620 F.3d…
…product for reasons other than sale within the control of the manufacturer or application holder.” Hmmmm . . . . . This is not the first time Connecticut has put…
…FDA forfeiture decision. But that’s the topic of today’s post . . . a recent and interesting case concerning generic ACTONEL (risedronate sodium) Tablets approved under NDA No. 020835. And…
…to the December 2003 enactment of the Medicare Modernization Act (“MMA”) is alive and kicking. . . . and will likely be around for years to come. Sometimes FDA’s decisions…
…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…
…a request for an exemption from further reporting of this malfunction . . . .” Draft Guidance, at 12. (We wrote about a Warning Letter portending FDA’s new position here.) Therefore, unless…
…Inc., U.S. Smokeless Tobacco Company LLC, R.J. Reynolds Tobacco Company, American Snuff Company, LLC, Santa Fe Natural Tobacco Company, Inc., and Lorillard Tobacco Company argue that the Final Guidance was…
…Yoplait USA argued that according to FDA yogurt may contain MPC. Defendants filed a motion to dismiss arguing, among other things, that primary jurisdiction barred Taradejna’s claims. As explained by…
…that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) ANDA No. 79-081 for a generic version of COMBIVIR (lamivudine and zidovudine) Capsules, and that contains the first Paragraph IV certification to an Orange…