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Deston Therapeutics Stands By Safety and Efficacy of Auralgan After FDA Action
Date:2/25/2011

ts statements or its pleadings that undermines the safety and efficacy of Auralgan as a treatment for ear pain and inflammation."

At this time the government's claims are only allegations in a legal proceeding.  Until a court makes a determination on this issue, it remains legally unresolved whether Auralgan qualifies as a "new drug" product.  

Recently, FDA has begun to take actions against classes of products that it believes should not be categorized as "old drugs" and instead should be regulated as "new drugs".  Unlike previous actions, FDA did not take action against both Auralgan and its generic substitutes, but instead, has solely focused its actions on Auralgan.  Currently, Auralgan represents 3% of the market for this class of drug products, with generic substitutes accounting for the other 97%.  FDA has not announced any action against any of these generic competitors or explained whether it intends to take any action against these products in the future.

History of Auralgan

Auralgan, is a solution of antipyrine and benzocaine and has been marketed in the United States since 1947 as a treatment for ear pain and inflammation associated with acute otitis media ("AOM").  

When Deston acquired the rights to Auralgan in 2006, this product and other generic equivalents had been marketed for over fifty years.  During this fifty year period, FDA had never taken enforcement action against any manufacturer for selling these types of drug products as unapproved "new drugs".  FDA's last official statement regarding the regulatory status of Auralgan occurred in 1981 when the Agency's Assistant to the Director, Division of Drug Labeling Compliance said that the Agency had not made a determination whether Auralgan qualified as a "new drug."

During this fifty year period of marketing, Auralgan was the subject of clinical trials supporting its use as safe and effective.  Additio
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SOURCE Deston Therapeutics LLC
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