Branded-generic trade names

Executive Summary

FDA guidances on drug names will close loophole that allows generic firms that distribute the drug but do not hold the ANDA to escape FDA trade name review for branded generics. The Institute for Safe Medication Practices points out that Andrx's Procet brand of generic hydrocodone/acetaminophen, not yet marketed, is similar to Percocet (oxycodone/acetaminophen) and shares the indication for moderate to moderately severe pain. Procet did not go through review by FDA's drug name working group because the ANDA was held by Mallinckrodt