Joint Meeting: FDA Anesthetic and Analgesic Drug Products Advisory Committee & Drug Safety and Risk Management Advisory Committee
The Food and Drug Administration (FDA) announces a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss supplemental new drug application (sNDA) 021306, for BUTRANS (buprenorphine) transdermal system submitted by Purdue Pharma L.P., evaluating BUTRANS in pediatric patients ages 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the findings of the clinical study of BUTRANS conducted in pediatric patients, and whether they support additional labeling.
More information, including how to submit comments, is available via the Federal Register notice.