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Auralgan otic solution seized by government officials
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.
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Report: Exclusivity period for biotech drugs may be reduced to seven years
WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.
According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.