Mallinckrodt's SpecGx LLC Receives FDA Complete Response Letter for Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride)

SpecGx LLC received a Complete Response Letter from the FDA regarding its NDA for an abuse-deterrent, immediate-release reformulation of Roxicodone. The FDA requested further evaluation for potential approval. SpecGx plans to discuss the FDA's guidance and continues efforts to mitigate opioid abuse through technology and community programs.