SILVER SPRING, Md. — The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.
The FDA announced the seizure of about $16.5 million worth of Auralgan otic solution made by Brooks, Ky.-based Integrated Commercialization Solutions. Chapel Hill, N.C.-based Deston Therapeutics manufactures the drug, while ICS warehouses it.
The FDA said Deston’s sale of the drug violates federal law because it does not have approval from the FDA, which issued a warning letter to the company in February 2010.
The FDA started the Unapproved Drugs Initiative in 2006 to target companies selling drugs that have not gone through the agency’s approval process. In most cases, the drugs are in a sort of regulatory limbo, having entered the market before the FDA adopted its current drug-safety standards in 1938, with some of them existing since the 1800s.