Six High-Strength Acetaminophen Drugmakers Missed Product Removal Deadline

The FDA said Mar. 27 that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet.

All but six manufacturers voluntarily withdrew their applications for the combination product. On Thursday, the FDA began the process of removing approvals for the remaining manufacturers.

The six remaining manufacturers with approvals are Leitner Pharmaceuticals, AbbVie, Nesher Pharmaceuticals USA, Pharmaceutical Associates, Ranbaxy Laboratories and West-Ward Pharmaceutical.

Five of the companies filed for voluntary withdrawal by the FDA’s January deadline, but their submissions lacked sufficient data. The fifth, Leitner, did not file, so the agency has initiated steps to withdraw the applications of all six.

The FDA’s ban took effect Jan. 14. At the time, the agency said more than half of the brand and generic drugmakers had met the deadline.

When it laid out the ban in 2011, drugmakers were given a three-year timetable to phase out the higher-dose products, which carry the risk of severe liver injury.

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