On July 21, 2016, the U.S. International Trade Commission (“Commission”) issued a press release announcing their vote to institute an investigation of Certain Potassium Chloride Powder Products (Inv. No. 337-TA-1013).
By way of background, this investigation is based on a June 15, 2016 complaint filed by Lehigh Valley Technologies, Inc. of Allentown, Pennsylvania, Endo Global Ventures of Bermuda, Endo Ventures Ltd. of Ireland, and Generics Bidco I, LLC d/b/a Qualitest Pharmaceuticals and Par Pharmaceutical of Huntsville, Alabama alleging violation of Section 337 by way of unlawful importation into the U.S., selling for importation, and/or selling within the U.S. after importation certain potassium chloride powder products, including importing and selling a “Potassium Chloride for Oral Solution, USP, 20 mEq” product that is allegedly not approved by the U.S. Food and Drug Administration (“FDA”), and unfairly competing with Complainants through the false and misleading packaging, marketing, promotion, distribution, and sale of the Proposed Respondents’ unapproved potassium chloride powder products. See our June 15, 2016 post for more details on the complaint.
According to the Notice of Investigation, the Commission has identified Viva Pharmaceutical Inc. of Canada, Virtus Pharmaceuticals, LLC of Tampa, Florida, and Virtus Pharmaceuticals OPCO II, LLC of Nashville, Tennessee as the respondents.
Lastly, Chief ALJ Bullock issued a notice indicating that MaryJoan McNamara will be the presiding Administrative Law Judge in this matter.