Ben Venue Laboratories, Inc. Regulatory and Manufacturing Update
Bedford, OH – January 22, 2013 – Ben Venue Laboratories, Inc. (Ben Venue) announced that it has voluntarily entered into a consent decree with the U.S. Food and Drug Administration (FDA) that relates to current Good Manufacturing Practice requirements. Under the terms of the consent decree, Ben Venue is permitted to continue to manufacture and distribute more than one hundred important drugs that are essential for patient care. Ben Venue is also permitted to continue drug-development activities, and may file abbreviated new drug applications (ANDAs), and, as remediation progresses to the FDA's satisfaction, receive ANDA approvals and manufacture other products. Approvals of new drugs would allow the company to meet future patient needs. The consent decree is subject to approval by the U.S. District Court for the Northern District of Ohio.
To date, Ben Venue has invested more than $300 million to upgrade its facilities, making necessary improvements and changes to processes to address the manufacturing-related issues that resulted in the company's decision to voluntarily halt manufacturing in November 2011. Ben Venue has demonstrated progress in improving manufacturing processes, and announced in October 2012 that limited production had resumed. Since that time, production has resumed on additional manufacturing lines.
Ben Venue, in partnership with the FDA, is committed to addressing drug shortage and ensuring critical medicines reach the people who need them. We continue to work closely with the FDA and share the goal of returning to production to manufacture safe and effective medicines.
Specific product availability information is located at www.bedfordlabs.com. Bedford Laboratories is a division of Ben Venue. For any questions, please contact the Bedford Laboratories Client Services Team at 1.800.562.4797.
Media inquiries can be directed to [email protected]gelheim.com.