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news.The US Food and Drug Administration (FDA) has approved Watson Pharmaceuticals' Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8mg strengths.
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Watson Pharma said that the approved drug is generic equivalent to Cephalon’s Fentora tablets.
Fentora is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.
Earlier, in Cephalon 3 June 2008 Cephalon’s wholly-owned subsidiary CIMA LABS have filed a suit in the US District Court in Delaware against Watson Pharmaceuticals and its wholly-owned subsidiary, Watson Laboratories, for infringement of US Patent nos.6,200,604 and 6,974,590, which cover methods of use for the Cephalon product Fentora (fentanyl buccal tablet) [C-II].
With this current approval the a decision on Cephalon’s lawsuit alleging that Watson’s product infringes various Cephalon patents remains pending in the US District Court for the District of Delaware.