Pharma

$16.5M in drugs seized in raid; FDA says Deston sold unapproved products

U.S. Marshals have seized $16.5 million worth of Auralgan Otic Solution, an ear infection drug that the U.S. Food and Drug Administration says Deston Therapeutics has been marketing without approval.

Federal marshals have seized $16.5 million worth of drugs from Chapel Hill, North Carolina-based Deston Therapeutics that the U.S. Food and Drug Administration says the company has been selling without approval.

U.S. Marshals on Feb. 16 seized all lots of Auralgan Otic Solution from the Brooks, Kentucky warehouse of Integrated Commercialization Solutions, a storage and distrbution company. Auralgan is a prescription drug used to treat pain and inflammation associated with ear infections.

The FDA said that selling Auralgan violates the law because Deston’s product does not have FDA approval and its labeling does not include adequate directions for use.

“The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness and quality,” Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a prepared statement. “We will remain vigilant in our efforts to protect consumers from unapproved products.”

Calls to Deston were not returned. The FDA last February sent Deston a warning letter that cited the company for distributing “unapproved new drugs and misbranded drugs.” The FDA followed with warnings in April, June and September that Auralgan was unapproved. The FDA said that its actions on Deston are part of an initiative started in 2006 to get unapproved drugs approved or off the market.