The FDA has approved ImaRx Therapeutics’ lot release request for its urokinase drug product, a thrombolytic or clot-dissolving agent indicated for the treatment of acute massive pulmonary embolism.
This is the first lot to be released with extended expiration dating, said 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,” said Bradford A. Zakes, president and CEO of ImaRx.
In January, ImaRx and Microbix Biosystems signed a letter of intent to manufacture urokinase and to continue a stability program to evaluate the potential for further expiration extensions beyond September 2009 for unlabeled vials of urokinase inventory.