Wednesday, June 27, 2018

Pain Therapeutics (PTIE) ; FDA rejects the approval of REMOXY ER



Pain Therapeutics reports the FDA Advisory Committee voted 14 to 3 against the approval of REMOXY ER (oxycodone extended-release capsules) for the management of pain 
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 7, 2018 for completion of its review of the New Drug Application for REMOXY ER. (DRRX)


** the day before **

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