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Re: WeeZuhl post# 292002

Tuesday, 06/19/2018 3:24:53 PM

Tuesday, June 19, 2018 3:24:53 PM

Post# of 415312
One week from today.

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm608768.htm

June 26, 2018:

The committees will discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.



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