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Title
Regulatory Status of the Buccal Fentanyl sNDA Updated.
Abstract
The article reports that the U.S. Food and Drug Administration has accepted Cephalon's supplemental New Drug Application for fentanyl buccal tablets for the management of breakthrough pain in opioid-tolerant patients with chronic pain. According to the report, the study provides an evaluation of the onset of pain relief from 10 minutes to 2 hours, and has information regarding bioequivalence data for two routes of administration.