FDA Warns Illegal Ibuprofen Marketers

20 August 2009 (Last Updated August 20th, 2009 18:30)

The US Food and Drug Administration (FDA) has issued warning letters to eight companies accused of marketing unlawful over-the-counter topical drug products containing the pain reliever ibuprofen. The products, which contain ibuprofen, are unapproved new drugs that require an approved new

The US Food and Drug Administration (FDA) has issued warning letters to eight companies accused of marketing unlawful over-the-counter topical drug products containing the pain reliever ibuprofen.

The products, which contain ibuprofen, are unapproved new drugs that require an approved new drug application in order to be legally marketed.

Although orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation for some time, there are no approved applications for topical ibuprofen products.

The FDA Centre for Drug Evaluation and Research director of the Office of Compliance Deborah M Autor said that these companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so.

The FDA has requested a written response from the companies within 15 business days.

The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu), BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories), Ibunex Topical Ibuprofen (Core Products International),
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products), IB-RELIEF (MEKT LLC), Profen HP (Ridge Medical Products), IbuPRO-10 Plus (Meditrend dba Progena Professional Formulations) and IBU-RELIEF 12 (Wonder Laboratories).