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Hospira Works With FDA to Help Avert Methotrexate Shortage; Shipping One Month's Supply of New Product Immediately and on Track to Ensure Sustainable Supply
Date:2/21/2012

ugh our continued partnership with the FDA, we will be able to avert a drug shortage crisis for methotrexate. 

"Accelerating the manufacture and delivery of methotrexate is a top priority for our entire company -- we have been, and will continue to do, everything we can to bring more product to the market. In fact, we have been working to address this issue since late last year when we first became aware of potential manufacturing challenges with other suppliers.

"As a result of those efforts, I'm thrilled to relay that, 24 hours ago, we began directly shipping 31,000 vials of new product -- enough to address more than a month's worth of demand -- and it is being received in hundreds of our nation's hospitals and treatment centers today. This represents the first step in our commitment to provide uninterrupted supply of this critical drug.

"Our ability to increase methotrexate production is contingent upon two things -- additional active ingredient and a streamlined system for product manufacture and release. Working in close cooperation with and approval from the FDA, we are able to achieve both. We worked aggressively and creatively to secure as much additional active ingredient as we could obtain by scouring the globe for FDA-approved active pharmaceutical ingredient (API) that we simply didn't have registered, but was in use by other companies who also manufacture the drug, to facilitate our qualification of the suppliers.

"As we speak, we are transporting well over 100 kilograms of new active ingredient to our manufacturing facility from locations around the world.

"Bolstered by our newly secured active ingredient, our manufacturing facility is literally working day and night to turn it into product.

"As a result, next week, we'll release an additional 34,000 vials. And by mid-March, we'll have enough product not only to meet the full market demand, but also to begin est
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SOURCE Hospira, Inc.
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