You are here

FDA Approves 12-Month Shelf Life for Taxus Stent System

VANCOUVER, May 22 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) corporate partner, Boston Scientific ("BSC"), today announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of BSC's TAXUS® Express(2)(TM) paclitaxel-eluting coronary stent system in the United States to twelve months from the current shelf life of nine months. The decision was based on data submitted by BSC 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 twelve months. The new TAXUS U.S. shelf life is longer than any competing product, as stated by BSC.

The extended expiration date applies to all sizes of the TAXUS system for sale in the United States. BSC said it would immediately begin updating labels to reflect the twelve-month expiration date. The shelf life for the TAXUS system outside the United States remains unchanged at 18 months.

Source: Angiotech Pharmaceuticals, Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation