MORRISTOWN, N.J. The Food and Drug Administration has given tentative approval to Watson Pharmaceuticals for a generic painkiller for cancer patients, Watson said.
Watson’s fentanyl citrate buccal tablets are used to treat breakthrough pain in cancer patients who are taking another opiate pain medication. The drug, a generic version of Cephalon’s Fentora, will be available in the 100-, 200-, 300-, 400-, 600- and 800-microgram strengths.
Fentora had sales of around $170 million during the 12-month period ended April 30, according to IMS Health.
Tentative approval means that the drug meets the FDA’s conditions for approval but can’t receive full approval until the patents covering the branded version expire. The patents covering Fentora will expire in March 2019.