USITC Institutes Section 337 Investigation of Certain Clidinium Bromide and Products Containing Same

April 18, 2018
News Release 18-045
Inv. No. 337-TA-1109
Contact: Peg O'Laughlin, 202-205-1819
USITC Institutes Section 337 Investigation of Certain Clidinium Bromide and Products Containing Same

The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain clidinium bromide and products containing same.  The products at issue in the investigation are capsules containing 2.5 mg of clidinium bromide and 5 mg of chlordiazepoxide hydrochloride as active ingredients.

The investigation is based on a complaint filed by Valeant Pharmaceuticals North America LLC of Bridgewater, NJ, and Valeant Pharmaceuticals International, Inc., of Quebec, Canada, on February 20, 2018.  The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain clidinium bromide and products containing same that the complainants allege are marketed using false or misleading advertising concerning the FDA approval status of the imported products, thus constituting unfair methods of competition under the Lanham Act, 15 U.S.C. § 1125(a).  The complainants request that the USITC issue a general exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.

The USITC has identified the following as respondents in this investigation:

Bi-Coastal Pharma International LLC of Shrewsbury, NJ;
Bi-Coastal Pharmaceutical Corporation of Shrewsbury, NJ;
ECI Pharmaceuticals LLC of Fort Lauderdale, FL;
Virtus Pharmaceuticals LLC of Tampa, FL; and
Virtus Pharmaceuticals OPCO II LLC of Nashville, TN.

By instituting this investigation (337-TA-1109), the USITC has not yet made any decision on the merits of the case.  The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing.  The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.

The USITC will make a final determination in the investigation at the earliest practicable time.  Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation.  USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.

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