If you purchased and/or paid-for (in whole or in part), for personal use and not for resale, Bupropion Hydrochloride XL (150 mg) and/or Budeprion XL (300 mg) manufactured by Impax, your rights may be affected by a class action settlement.
A class action settlement has been reached in a class action lawsuit against Impax Laboratories, Inc. (Impax) and Teva Pharmaceuticals USA Inc (Teva) (collectively “Defendants”) in the United States District Court for the Eastern District of Pennsylvania (styled Multi-District Litigation No. 2107, In re: Budeprion XL Marketing & Sales Litigation , Class Action Case No. 2:09-CV-2811), alleging, among other things, that two formulations of extended-release bupropion hydrochloride (bupropion hydrochloride XL 300mg manufactured by Impax Laboratories, Inc. and marketed by Teva Pharmaceuticals USA, Inc. under NDC number 0093- 5351 using the trade name Budeprion XL and bupropion hydrochloride XL 150mg manufactured by Impax and marketed by Global Pharmaceuticals under NDC number 0115-6811) do not work as well as the brand equivalent, Wellbutrin XL, marketed by GlaxoSmithKline, according to the Impax Bupropion Hydrochloride XL class action settlement notice.
The plaintiff class in the Impax Bupropion Hydrochloride XL class action lawsuit has been defined as the following:
All individuals in the United States who, from 2006 to the present, purchased and/or paid-for (in whole or in part), for personal use and not for resale, Bupropion Hydrochloride XL (150 mg) and/or Budeprion XL (300-mg) manufactured by Impax. Excluded from the class are Defendants, any parent, subsidiary or affiliate of Defendants, and their officers, directors, and employees, who are or have been employed by Defendants, and any judicial officer who may preside over this action.
The Impax Bupropion Hydrochloride XL settlement reportedly provides injunctive relief only and no payments will be made to class members. The proposed settlement provides: that (1) Defendants will make permanent certain changes to the prescribing insert for BP XL regarding use of the trade name Budeprion XL; (2) Defendants will make permanent changes to the prescribing insert for BP XL to indicate that it meets USP Dissolution Test 6; and (3) If 500-count bottles of BP XL are sold in the future, Defendants will not sell the 500-count bottles without the changes submitted to the U.S. Food and Drug Administration (FDA) in December 2010 regarding the 500-count bottles or any subsequent change that supersedes the December 2010 submission. Further, Defendant Impax will (4) Implement compliance monitoring in an effort to ensure compliance with any then-current corrective action or preventative action plans regarding BP XL through 2013; (5) Implement compliance monitoring in an effort to ensure compliance with standard operating procedures regarding investigation of complaints through 2013; (6) Designate a senior quality and compliance officer who will oversee the quality of BP XL and report to one or more Board members twice yearly regarding that compliance through 2013; (7) Provide confirmation to plaintiffs’ counsel that this twice yearly report was made; (8) Post on the company website any future voluntary recalls relating to BP XL through 2013, to the extent appropriate under FDA regulations.
For additional information on the Impax Bupropion Hydrochloride XL settlement, contact 1-866-503-9129 or review the information and frequently asked questions on the Bupropion Hydrochloride XL settlement website: www.BudeprionXLsettlement.com or email the Settlement Administrator’s office at mail@BudeprionXLsettlement.com.
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