FDA Pushes Back On So-Called Legacy Drugs

Law360, New York (October 22, 2007, 12:00 AM EDT) -- Earlier this fall, a spotlight brightened on a larger issue as the U.S. Food and Drug Administration banned prescription cold and cough medications: Thousands of drugs are on the market that have never gone through proper approval channels.

The recent scrutiny of unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs, was the latest in an FDA crackdown of unapproved drugs.

"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," said Steven K....
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