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…drug product containing new and old actives, the NCE component must have been approved first, followed by the combination drug. In that case, NCE exclusivity granted with respect to the…
…tobacco product with the predicate tobacco product with respect to all product characteristics. These include design features (components, subcomponents, specifications, etc.), a listing of ingredients (ingredient names, common names, the…
…can refer to our previous post for the details. However, in a nutshell, ANDA sponsor Apotex (the only company to have thus far commented on FDA’s draft PLAIR guidance) was,…
…proffered as support and the representation at issue at the time it is made, and the representation is supported by competent and reliable scientific evidence, including tests, analysis, research, and…
…Inc., (the Company) for falsely advertising its sunscreen product as “all natural” in violation of Sections 5 and 12 of the FTC Act. On December 12, 2016, the FTC issued…
…Order as a whole. Thus, regardless of what happens at the Supreme Court, POM will be subject to at least a major part of the FTC’s Order. However, POM asserts…
…Nutrition, Inc., (No. 92-3087), 2010 WL 2811203 (F.T.C. July 14, 2010); Stipulated Final J. and Order for Permanent Inj. And Other Equitable Relief, FTC v. Iovate Health Sciences USA, Inc.,…
…August 27, 2015 PDUFA date and approval. Drugs that are first-to-market often enjoy considerable benefits over second-comers. U.S. payers, for example, are quick to cover new drugs, and products that…
…reflected the November 11, 2009 date, FDA nevertheless approved an ANDA on November 10, 2009. (Consistent with the court’s order, the generic version was presumably not launched until November 11, 2009.)…
…including Monday, May 11, 2015, to and including Friday, June 3, 2016) is far too long a period. “In recent cases with expedited briefing, as is the case here,” notes…
By Riëtte van Laack – The Court of Appeals for the Eleventh Circuit overturned a contempt order against Hi-Tech, Jared Wheat, Stephen Smith, and Dr. Terrill Mark Wright (“Hi-Tech”) because,…
…found FDA’s August 18, 2014 Letter Decision permitting the approval of ANDAs for generic PRECEDEX not arbitrary, capricious, or otherwise not in accordance with law, but rather, a decision based…
…document issued in March 2011, is titled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” The second, a draft guidance document issued April 22, 2011, is titled “Establishing that…
…with false and misleading advertising because POM’s claims that POM’s products (POM Wonderful 100% pomegranate juice, POMx Pills, and POMx Liquid) prevent, reduce the risk of, or treat heart disease,…
…has filed over the past few years, including Docket Nos. FDA-2008-P-0529, FDA-2009-P-0555, FDA-2010-P-0642, FDA-2012-P-0555, FDA-2013-P-0025. In each instance (except for one petition that was apparently withdrawn – FDA-2013-P-1128), FDA has…