BEN VENUE LABORATORIES — VOLUNTARY SHUTDOWN (11/19/11)

SHUTDOWN OCCUS AS RESULT OF SIGNIFICANT MANUFACTURING AND QUALITY CONCERNS

On November 19, 2011, Ben Venue Laboratories, Inc. (“BVL”) announced the voluntary shutdown of manufacturing and distribution at its site in Bedford, Ohio due to significant manufacturing and quality concerns. BVL’s decision to shut down is a result of their own findings. The company notified the U.S. Food and Drug Administration as soon as they made the decision to shut down. Manufacturing and distribution of all products from this site are currently on hold; however, products already in distribution will remain on the market until further analysis is complete.

FDA is working with BVL to address the impact this shutdown may have on the availability of certain drugs. FDA has been and will continue to work with BVL in prioritizing the quality issues to be addressed in order to help bring the company back to production as soon as possible.

BVL is a large manufacturer of sterile injectable drug products. It also manufactures the chemotherapy drug Doxil for Janssen. FDA is working closely with Janssen and BVL to address the critical shortage of Doxil and will explore all options in order to make the product available again as soon as possible. Updated information regarding the availability of Doxil can be found at www.doxil.com¹.²

FDA continues to work with BVL to assess and address their ongoing quality and manufacturing issues. While FDA continues to investigate this matter, patients potentially affected by the BVL shutdown should consult with their health care provider before discontinuing or changing their medications.

While ensuring that the quality of products being manufactured remains the responsibility of the companies that produce them, we are committed to working with BVL to return safe and effective products to consumers as quickly as possible. FDA is actively working to prevent and mitigate prescription drug shortages and using its regulatory flexibility to facilitate access to safe and effective medicines for America’s families.

–