ImaRx Therapeutics has revealed that the FDA has approved the company's most current lot release request for urokinase drug product. This is the first lot to be released with extended expiration dating.
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Urokinase is a thrombolytic or clot-dissolving agent indicated for the treatment of acute massive pulmonary embolism. ImaRx is continuing its stability program to evaluate the potential for further expiration extensions beyond September 2009 for unlabeled vials of urokinase inventory.
Bradford Zakes, president and CEO of ImaRx, said: “The FDA approval of urokinase lot release brings several advantages to ImaRx. The extended expiration dating allows us to unlock the value from our unlabeled urokinase inventory. We will also benefit from cost-savings associated with prolonged shelf-life for future urokinase supplies.”
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