FDA Pulls Remaining ANDAs of High-Dose Acetaminophen Products

July 22, 2014

After asking drugmakers in 2011 to voluntarily withdraw pain medications containing more than 325 milligrams of acetaminophen over safety issues, the FDA has pulled the remaining ANDAs from firms that either failed to submit sufficient data with their withdrawal applications or didn’t submit an application at all.

Three of the holdout ANDAs belonged to AbbVie while the rest belonged to Leitner Pharmaceuticals, Nesher Pharmaceuticals, Watson Laboratories (which is now Actavis) and West-Ward Pharmaceutical, according to a July 14 FDA notice released July 16. Watson did submit the proper withdrawal request, the FDA said, but the company erroneously was left off a March 27 withdrawal notice of 108 other ANDAs, which is why it is listed with this notice.

West-Ward has said previously that it voluntarily withdrew its application and received acknowledgement of the withdrawal from the FDA on March 25.

Five of the remaining ANDAs submitted withdrawal requests that either omitted required information that the products were pulled for safety reasons, or failed to cite the relevant regulatory provision, the FDA said. Leitner, which holds the sixth ANDA, never submitted a withdrawal request.

None of the drugmakers asked for a hearing when the FDA moved to forcefully withdraw approval, the agency said.

The FDA first asked drugmakers in 2011 to withdraw their ANDAs over revelations that combination drugs with more than 325 milligrams of acetaminophen per dose could cause serious liver damage.

ANDA holders were given three years to phase out their high-dose products, with a deadline of Jan. 14 of this year. The FDA said at the time that more than half of the effected drugmakers met the deadline. All of the products had been withdrawn from the market by the end of March.

None of the ANDA holders responded to a request for comment by press time.— Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.