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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.



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