September 23, 2008
FDA Issues Warning About Unapproved Drugs
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.
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.