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

the evidence presented in its Citizen Petition, provide a thorough explanation for the reasons that it believes the combination is not GRAS/E, the matter is now up to a court to make a final legal decision on the new drug status of the articles that have been seized.  Until the court rules on the old drug- new drug issue for the seized goods,  the matter has not been legally resolved Mr. Allera noted.  

"We continue to believe, as we always have, that Auralgan is a safe and effective treatment for ear pain and inflammation," said Mr. Preston.  "Deston looks forward to working with the government to resolve all outstanding issues related to the regulatory classification of this drug product."

According to the original complaint, Deston has thirty-five days to claim the seized Auralgan, and after claiming the seized goods, Deston has 20 days to file an answer to the complaint.  Mr. Preston said that Deston is currently exploring its legal options regarding how best to respond to this seizure.


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