Pain Therapeutics, Inc. (PTIE) said that the FDA has accepted a New Drug Application resubmission for REMOXY and has classified it as a Class 2 resubmission.
With the Class 2 designation, the FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011.
REMOXY is a twice daily, long-acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time.
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