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To answer the urgent need for Bedford Laboratories’ methotrexate, Ben Venue Laboratories (Ben Venue) has been actively working with the U.S. Food and Drug Administration (FDA) to expedite the availability of preservative-free methotrexate for injection USP (in both liquid and lyophilized formulations). As a result, Ben Venue has accelerated the review process and will immediately begin releasing a limited supply of methotrexate. This supply was produced before Ben Venue voluntarily suspended manufacturing of all products in November 2011 to address manufacturing-related issues at its facility.
Product will be allocated to oncology clinics, hospitals and pediatric facilities beginning Thursday, February 16, 2012 and will continue over the next several weeks. We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production.
Ben Venue has been working around the clock to implement changes needed to ensure a more sustained supply of the medicines we produce, and to address the manufacturing-related issues at its facility as noted in recent inspections by the FDA and other global regulatory agencies. Over the past three years, Ben Venue has invested more than $250 million to upgrade its facilities, and continues to invest millions more in order to restore production as quickly as possible. Ben Venue continues to work closely with the FDA with the shared goal of bringing methotrexate and other critical medicines we make back to market as quickly as possible. As we make progress and additional information becomes available, we will provide updates on our website.