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…also claimed that Skechers made deceptive claims about its Resistance Runner, Toners, and Tone-ups shoes. See Complaint 12- 16, Federal Trade Commission v. Skechers USA, Inc., No. 1:12-cv-01214 (N.D. Ohio…
…that Teva is entitled to 180-day exclusivity, and enjoin FDA from granting final approval to other ANDAs for generic RISPERDAL during Teva’s 180-day exclusivity period. The Orange Book currently lists…
…in particular) because they create an impermissible conflict with federal law. The two Petitions for Writ of Certiorari (here and here) were filed in February 2010 and present almost identical…
…2011 in Claremont, California. OOPD also created the Rare Disease Repurposing Database (“RDRD”) in 2010. The RDRD “offers sponsors a new tool finding special opportunities to develop niche therapies that…
…a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that…
…(D-CA), who was instrumental in the passage of the ODA, also commemorated the anniversary and Klugman’s passing (see here). We at Hyman, Phelps & McNamara, P.C. are celebrating the ODA’s…
…eligible for 180-day exclusivity. Teva also contends that because FDA “failed to provide official notice of the ‘delisting’ for several months following the submission of Teva’s ANDA,” the delisting does…
The National Institutes of Health (“NIH”) recently launched a database of labels of dietary supplements being sold in the United States. The database includes, among other information, directions for use,…
…. that lasts until April 13, 2007 at 5:00 pm.” Zydus also requests that FDA “approve all complete amlodipine besylate ANDA[s] that are currently pending.” In support of its requests,…
…several grounds – specifically, that Teva is not challenging final agency action, Teva’s claims are not ripe, Teva has not suffered sufficient injury for Article III standing, and Teva has…
…restore the company’s paragraph IV patent certification, and declare that Teva is entitled to 180-day exclusivity. Teva also requests that the court enjoin FDA from granting final approval to other…
…Mylan would immediately appeal this Court’s decision, and that even if they appeal, may not prosecute the appeal timely so as to try to dissolve or stay the injunction prior…
On September 12, 2008, the U.S. Court of Appeals for the District of Columbia heard oral argument and ruled in Teva Pharmaceuticals USA, Inc. v. Leavitt, which concerns the availability…
…until approval, and judicial review would thus be similarly circumscribed.” FDA also notes that a policy of not making advance decisions “is also consistent with Congress’s choice to vest FDA…
…position, we would have to accept the proposition that even partial inadvertence is sufficient. The electronic version of the Orange Book reflected the withdrawal of the ‘952 patent at least…