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# Panel Recommends Approval of SpecGx Oxycodone Formulation
- URL: https://www.fdaweb.com/panel-recommends-approval-of-specgx-oxycodone-formulation/
- Published: 2018-11-15T12:00:00.000Z
- Updated: 2026-09-15T00:44:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142835

A joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 10 to 7 to recommend approval of Mallinckrodt subsidiary SpecGx’s investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Additionally, panel members voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by nasal route of abuse, and 10 to 7 that the drug should not be labeled as an abuse-deterrent product by intravenous route of abuse. SpecGx says it is developing the reformulated Roxicodone with properties designed to deter intravenous and intranasal abuse.