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…Show Cause Why Defendant Should Not Be Held in Contempt, No. 07-cv-00001, Docket No. 4 (D.N.J. Sept. 12, 2014). Specifically, many commentators fear that the FTC is attempting to impose…
…PLAN B One-Step situation . . . . If FDA has, in fact, granted (or will grant) 3-year exclusivity vis-à-vis the change approved in the April 30th supplement (i.e., OTC…
…Corporation’s ZOMETA (zoledronic acid) Injection, 4 mg/5 mL (or 0.8 mg (base)/mL). ZOMETA is approved under NDA No. 021223 and is listed in the Orange Book with three product entries. …
…are not considered drugs (e.g., blood transplants, organ transplants, etc.). The Government is expected to file a brief to Regenerative’s response to the show cause order by October 24, 2011….
…last week by Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) against FDA in a case involving marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL products. The 37-page opinion, which…
…the Order and Injunction. Novo promptly appealed the decision to the Federal Circuit, where the company is seeking a stay of the district court’s Order and Injunction. The district court’s…
…was not a party there . . . . This is too clever by half. . . . Nu-Pharm is attempting to litigate here the issue resolved by Judge Posner,…
…1, 2012), United States v. Bayer Corp., 2015 U.S. Dist. LEXIS 74118 (D.N.J. June 8, 2015), POM Wonderful, LLC v. FTC, 777 F.3d 478, 490 (D.C. Cir. 2015). The Court’s…
…to FDA in the case is that provided by framework laid out by the U.S. Supreme Court in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837,…
…of Defendant Food and Drug Administration (FDA), in Docket No. FDA-2014-N-0087 is STAYED; directing that this order is to remain in effect until September 2, 2014. Temporary Restraining Order Granted….
…Or On The Order Of A Licensed Veterinarian,” or any similar restrictive statement and, thus, includes both drugs that are controlled substances and non-controlled substances. OAC Ann. 4729-9-01(A). Under the…
…is valid. Holiday CVS, 77 Fed. Reg. at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. and SND Health Care, L.L.C.; Decision and Order, 81 Fed. Reg. 79,188, 79,218-19 (Nov. 10,…
…occur for the eligible prescription drug. Information related to the importation (e.g., date, location, warehouse). Florida has 12 months to submit a pre-import request. FDA would need at least 30…
…Agent. Imported prescription drugs will be sampled and tested by a qualified laboratory; the drugs will also be repackaged and relabeled prior to importation to meet U.S. drug labeling requirements….
By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance…