FDA won’t approve 108 ANDAs for high-dose acetaminophen products

April 3, 2014

FDA will not be approving 108 abbreviated new drug applications (ANDAs) for prescription medications that contain more than 325 mg of acetaminophen, according to a March 27th Federal Register notice.

FDA will not be approving 108 abbreviated new drug applications (ANDAs) for prescription medications that contain more than 325 mg of acetaminophen, according to a March 27th Federal Register notice.

FDA had announced in January 2014 that it would reduce the maximum dosage unit strength of acetaminophen in prescription combination products in order to protect the public against the risk of acetaminophen-induced liver injury.

“We asked product sponsors to limit the maximum amount of acetaminophen per dosage unit to 325 mg and, for those products containing more than 325 mg of acetaminophen per dosage unit, to submit requests that FDA withdraw approval of their applications. FDA asked that all such requests be made before January 14, 2014,” according to the FDA.

Of the 108 ANDAs listed in the notice, the product sponsors have complied and waived their opportunity for a hearing. However, six drug manufacturers have not withdrawn their applications as of the January 14 deadline, but have stopped marketing their products. These manufacturers include AbbVie, Leitner Pharmaceuticals, Nesher Pharmaceuticals, Pharmaceutical Associates Inc., Ranbaxy Laboratories, and West-Ward Pharmaceutical Corp., according to another notice in the Federal Register.

FDA is asking all drug manufacturers of prescription products containing more than 325 mg of acteminophen per dose to submit requests to withdraw these ANDAs. If manufacturers do not, FDA said it will exercise its authority under the Food, Drug, and Cosmetic Act to initiate withdrawal proceedings for these products that are still on the market three years from this March 2014 notice.