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

nally, numerous health organizations and institutions have stated that Auralgan is safe and effective.  The United States National Library of Medicine's Medline Plus and the National Institute of Health's National Center for Biotechnology Information have stated on their webpages that Auralgan is a safe and effective treatment for ear pain and inflammation associated with AOM.  The American Academy of Pediatric and American Academy of Family Physicians along with the Institute for Clinical Systems Improvement published guidances recognizing Auralgan as a safe and effective treatment for ear pain in pediatric patients with AOM.

According to Mr. Preston, when Deston acquired Auralgan, it believed that this product qualified as an "old drug" because of the long marketing of Auralgan, the evidence supporting its safe and effective use, and the fact that the Federal Government has never concluded that it was a "new drug" or took action against the previous manufacturer of Auralgan.  

Deston was unaware that FDA believed that Auralgan was a "new drug" until the FDA informed Deston of this position last year.  In response to this information, Deston's legal counsel prepared and filed, on May 28, 2010, a "Citizen Petition" with the FDA, to make the case, point by point, why Auralgan was not a 'new drug'. Deston had expected a due process period whereby FDA would provide an in-kind formal response, explaining why they believed it was a 'new drug'.

Deston also began discussions with FDA regarding how to obtain FDA approval for Auralgan if, after addressing the Citizen Petition, the FDA decided the product qualified as a "new drug."  On February 15, 2011 – a day after the Federal Government seized Auralgan – Deston received a partial response to its Citizen Petition implying that the FDA has not yet made a determination on whether Auralgan qualifies as a "new drug" or an "old drug."  Because FDA has yet to review
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SOURCE Deston Therapeutics LLC
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