Watson's ANDA for Fentanyl Citrate Buccal tablets receives tentative FDA approval

Jun 24 2010

Watson Pharmaceuticals, Inc. (NYSE: WPI) announced that its subsidiary, Watson Laboratories, Inc. has received tentative approval today from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Fentanyl Citrate Buccal tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg. Watson's Fentanyl Citrate Buccal tablets are a generic version of Cephalon's Fentora®.  Fentora® is used to treat breakthrough pain (sudden episodes of pain that occur despite round-the-clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication.

Cephalon's legal action against Watson alleging that Watson's ANDA for Fentanyl Citrate Buccal tablets infringes certain of Cephalon's patents remains pending.  Final approval of Watson's application remains subject to the expiration of the automatic stay of approval imposed under the provisions of the Hatch-Waxman Act.

For the twelve months ending April 30, 2010, Fentora® had total U.S. sales of approximately $170 million according to IMS Health data.