Fentanyl Buccal Tablets Close to Receiving FDA Approval

Watson Laboratories, Inc. recieved tentative approval from the 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 Laboratories, Inc., is a subsidiary of Watson Pharmaceuticals, Inc.

The Buccal tablets are a generic version of Cephalon’s Fentora, which is used to treat breakthrough pain in cancer patients.