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…of Takeda Global Research & Development Center, Inc.’s (“Takeda’s”) diabetes drug ACTOS (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg. Watson, through its Complaint and Motion for a…
…orders to the local DEA office. 21 C.F.R. § 1301.74(b). Suspicious orders include orders of unusual size, orders that deviate substantially from a normal pattern and orders of unusual frequency. …
…approval. Essentially, Apotex’s argument rests on the premise that the New York District Court’s order only “purports to reset the effective date of [the company’s] approval to the expiration of…
…July 10, 2009 stay order – specifically, whether the July 10th order was intended to: (1) enjoin FDA from granting final approval to their applications; or (2) to enjoin Mayne…
…as opposed to Active Pharmaceutical Ingredients) from Canada, by traveling to Canada and purchasing drugs in pharmacies there, or by mail order, either through Internet websites or through telephone purchases. …
…here. After receiving 1,350 comments on the proposed model, CMS scrapped the proposed rule in 2017 following the change in administration (see our follow up blog post here). This ANPRM…
…element of the federal requirements, VAHS set forth to determine whether importing drugs from Canada could result in savings to Vermont consumers. Vermont Medicaid determined that importing drugs from Canada…
On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the…
…the agency, and that the online portal would continue to accept batch applications and single payments. Id. at 21,020- 21,021. NACDS also commented that the proposed rule was unclear on…
…complainant who, for example, submitted an unreliable or inadequately documented complaint to the Agency, CDRH now has committed to “follow-up communication” and a tracking system. This will allow submitters to…
…litigation; that judgment is entered for Pfizer Inc. and Pfizer Ltd. on the Amended Complaint and Amended Counterclaim, in accordance with the Court’s Opinion and Final Order which found that…
…make PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (“PBOS”) available Over-the-Counter (“OTC”) without age or point-of-sale restrictions upon the aproval of a supplemental New Drug Application (“SNDA”) submitted by the…
…the scope of interstate commerce since Regenerative obtains “components” to manipulate the stem cells from outside of the state. Second, and most amazingly, the Government argues that interstate commerce is…
…sufficient showing at this juncture to support its application for an Order to Show Cause” (Order at 1), is not clear. However, we expect that the company may well engage…
…and regulatory restrictions into a court order. FDA has 60 days to appeal from the court’s order to the Eleventh Circuit. Aside from an appeal, it is uncertain how…