Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

Samsa as I understand it, a positive panel review from AdCom simply moves Rexista towards the final PDUFA action date where/when the FDA will make their final labeling determinations and approval decisions.

Agenda
The committees will discuss new drug application (NDA) 209653, for oxycodone hydrochloride extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around the clock 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 the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.