FDA Advisory Committee Meetings


There are 3 days of FDA Advisory Committee meetings next week, including discussion of an ADF on January 15th.

In the Wednesday afternoon session, the committees will discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. 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 whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as to discuss the overall risk-benefit profile of the product.

To view the webcast of the discussion, visit this link where the FDA has provided additional information. Materials for all 3 of the committee meetings can be found here.