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Topical ibuprofen companies get FDA warning

The US FDA has issued warning letters to eight companies marketing unlawful OTC topical drug products containing ibuprofen

The US Food and Drug Administration (FDA) has issued warning letters to eight companies marketing unlawful OTC topical drug products containing ibuprofen.

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, require an approved new drug application in order to be legally marketed, says the FDA.

"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," said Deborah M Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

The FDA's warning letters advise the companies that they may not continue to market their products without its approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters, stating how they will correct these violations and prevent similar violations in the future.

The warning letters relate to: 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).

Ibuprofen is not included in any OTC drug monograph (the system under which some OTC drugs can be marketed without first obtaining agency approval).

24th August 2009

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