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RSS FeedsMallinckrodt`s SpecGx LLC Reports on Outcome of FDA Joint Advisory Committee on Abuse-Deterrent, Immediate-Release Reformulation of RoxicodoneŽ (Oxycodone Hydrochloride)
(WorldNews Africa)

 
 

15 november 2018 01:27:30

 
Mallinckrodt`s SpecGx LLC Reports on Outcome of FDA Joint Advisory Committee on Abuse-Deterrent, Immediate-Release Reformulation of RoxicodoneŽ (Oxycodone Hydrochloride)
(WorldNews Africa)
 


ST. LOUIS, Nov. 14, 2018 /PRNewswire/ -- SpecGx LLC (SpecGx), a subsidiary of Mallinckrodt plc (NYSE: MNK) that operates its Specialty Generics business, today announced that, in a joint meeting, the U.S. Food and Drug Administration`s (FDA`s) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve the SpecGx investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Additionally, the Committees voted 12 to 5 that the drug should be labeled as an...


 
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