Will KFDA limit amount of acetaminophen to 325 mg per dosage unit for Ultracet ER tablets?

The Korea Food and Drug Administration (KFDA) has asked manufacturers to reformulate prescription drugs containing acetaminophen so that a single dosage unit containing a maximum of 325 mg acetaminophen. This includes combination products of acetaminophen.

Now, industry’s interest has focused on the content of Ultracet extended release (ER) tablets, as Korean drugmakers are poised to develop...