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Wednesday, 12/12/2018 12:14:54 PM

Wednesday, December 12, 2018 12:14:54 PM

Post# of 38634
Mallinckrodt's SpecGx LLC Receives FDA Complete Response Letter for Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone (oxycodone hydrochloride) tablets

"We are evaluating the FDA's letter and will request a meeting in the coming weeks to discuss it further," said Matt Harbaugh, President, Specialty Generics. "We continue to believe this new abuse-deterrent formulation has the potential to mitigate opioid abuse and misuse, and though we're disappointed by the FDA's decision, we will continue to pursue a pathway to try to gain approval of the drug."

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