FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing...

FDA Approves Cimzia to Treat Crohn’s Disease

A new drug has been approved to help sufferers of Crohn’s disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn’s disease who have not responded...

FDA Warns Consumers Not to Use “Blue Steel” And “Hero” Products

The U.S. Food and Drug Administration is advising consumers not to purchase or use “Blue Steel” or “Hero” products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have...