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FDA Issues Warning About Unapproved Drugs

September 23, 2008

The U.S. Food and Drug Administration is warning companies marketing unapproved products to stop manufacturing and marketing or face charges.

The FDA specifically noted companies marketing unapproved ophthalmic balanced salt solutions, or BSS, and unapproved topical drug products containing papain. The federal agency said it was issuing the warning because it has received reports of serious adverse events associated with their uses.

“Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009,” the FDA said in a statement. “After these dates, all topical products containing papain must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved topical papain products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.”

A similar timetable was announced for companies marketing any unapproved topical drug products containing papain. No topical drug product containing papain has been approved by the FDA.




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