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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has got FDA's tentative approval on its abbreviated new drug application (ANDA) for Fentanyl Citrate Buccal tablets, 100mcg, 200mcg, 300mcg, 400mcg, 600mcg and 800mcg.
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Watson’s Fentanyl Citrate Buccal tablets are a generic version of Cephalon’s Fentora.
Fentora is used to treat breakthrough pain in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication.
Cephalon had received FDA approval to market Fentora (fentanyl buccal tablet) [C-II] on 25 September, 2006.
Cephalon’s legal action against Watson Pharma alleging that Watson’s ANDA for Fentanyl Citrate Buccal tablets infringes certain of Cephalon’s patents remains pending.
Watson said that final approval of its application remains subject to the expiration of the automatic stay of approval imposed under the provisions of the Hatch-Waxman Act.