Watson’s generic Fentora gets FDA approval
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.
Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.
The drug, used to treat breakthrough pain in patients with cancer, is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November, according to IMS Health. Breakthrough pain refers to flashes of pain that can’t be controlled through normal painkillers.
As the first company to file for approval of a generic version of the drug, Watson is legally entitled to 180 days’ market exclusivity in which to compete directly with the branded version.
Abstral OKed as breakthrough pain treatment for cancer patients
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.
The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.
“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” FDA Office of New Drugs director John Jenkins said.
The drug will have a Risk Evaluation and Mitigation Strategy, or REMS program, designed to minimize the risk of misuse, abuse, addiction and overdose, the FDA said.
Warning issued to consumers over extortionists posing as FDA agents, federal officials
SILVER SPRING, Md. — International criminals are posing as Food and Drug Administration special agents and other law enforcement officers in order to extort money from consumers, the FDA warned Friday.
The FDA said the criminals will call the victims, who often previously purchased drugs through “telepharmacies” or over the Internet, and tell them that purchasing drugs online or over the telephone is illegal. They then attempt to extort “fines” ranging from $100 to $250,000 and instruct victims to transfer the money to a designated location, usually in the Dominican Republic, threatening the victims with property searches, arrests, deportations or physical harm if they fail to comply.
“Impersonating an FDA official is a violation of federal law,” FDA associate commissioner for regulatory affairs Dara Corrigan said. “FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action.”