Cephalon, Inc. announced today receipt of a complete response letter from the Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.
The details can be read here.
Monday, September 15, 2008
Cephalon Receives Complete Response Letter Regarding Request for Expanded Fentora Label for Non-Cancer Breakthrough Pain
Posted by Amit at 8:18 PM
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