News & Updates

FDA Announces Withdrawals and Next Steps for Sponsors of Drug Products Containing Acetaminophen

Apr 3, 2014 Tags: Acetaminophen, FDA

On March 27, FDA announced separate actions on drug products containing more than 325 mg of acetaminophen; one for the ANDA sponsors who properly requested withdrawal of their applications by January 14, 2014, and one for those ANDA sponsors who made no request or made the request incorrectly. For the sponsors who requested withdrawal, the applications are withdrawn effective immediately and "[d]istribution of these products in interstate commerce without an approved application is illegal and subject to regulatory action..." For the companies that did not properly request withdrawal, FDA asks that they request a hearing within 30 days and submit data within 60 days.