FDA Warns Cos. About Marketing Ibuprofen Products

Law360, New York (August 20, 2009, 5:13 PM EDT) -- Progressive Emu Inc., Wonder Laboratories and six other drug manufacturers have received warning letters from the U.S. Food and Drug Administration that they are marketing pain-relieving ointments that include ibuprofen without federal approval, the FDA said Thursday.

The FDA put the companies on notice that they are promoting unlawful over-the-counter topical products containing ibuprofen and that the products require an approved new drug application before they can be marketed, the agency said.

“These companies have an obligation to the public to demonstrate to the FDA that...
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