FDA Approves 12-Month Shelf Life for Taxus System

Boston Scientific announced that the FDA has approved extending the shelf life of its Taxus Express2 paclitaxel-eluting coronary stent system in the U.S. to 12 months from the current shelf life of nine months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the Taxus system -- in particular the drug content, drug degradation profile and drug-release mechanism -- was maintained within FDA-approved specifications at 12 months. The new Taxus U.S. shelf life is longer than any competing product.

Medical News Today (http://www.medicalnewstoday.com/medicalnews.php?newsid=24942)