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Saturday, 04/01/2017 5:32:30 AM

Saturday, April 01, 2017 5:32:30 AM

Post# of 402480
Little scared about this.

Wednesday, April 5.

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm546576.htm

Agenda

The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.


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