FDA accepts Mallinckrodt NDA for hydrocodone/acetaminophen combo
This article was originally published in Scrip
Executive Summary
Mallinckrodt said its new drug application (NDA) for MNK-155, an extended-release oral formulation of hydrocodone and acetaminophen under investigation to manage moderate-to-moderately severe acute pain where the use of an opioid analgesic is appropriate, is now under review at the FDA.