Watson gets tentative approval for generic Fentora
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.
Orphan drug designation for Tolera’s diabetes drug
KALAMAZOO, Mich. The Food and Drug Administration has granted orphan drug designation to an investigational treatment for diabetes.
Tolera Therapeutics said Tuesday that the FDA had given the designation to TOL101, a monoclonal antibody for treating recent onset immune-mediated Type 1 diabetes. The drug is designed for patients aged 16 years and younger.
The FDA gives orphan drug designation to treatments for diseases and conditions that affect fewer than 200,000 people annually in the United States; though an orphan drug still is subject to the same regulatory scrutiny as any drug, the designation waives government filing fees and provides tax credits related to development costs and other support.
“We are pleased with this designation,” Tolera CEO John Puisis said. “Clinicians and patients need an effective and safe means to modulate the immune system, particularly for juvenile diabetes patients.”
Cephalon expands When Good Medicines Become Bad Drugs program with new partnership
FRAZER, Pa. Drug maker Cephalon has started a partnership with the American Chronic Pain Association and the American Pharmacists Association to promote appropriate use of pain medications, Cephalon said Wednesday.
The partnership expands Cephalon’s When Good Medicines Become Bad Drugs program and is designed to spread awareness of the dangers of abusing prescription drugs by creating educational materials developed with the APhA and ACPA for use in a select group of pharmacies. The company did not specify which pharmacies would participate.
“Pharmacists play a key role in educating the public about prescription medicines, and the expansion of this program provides hands-on resources to support those conversations with the goal of reducing prescription pain medicine abuse,” Cephalon chief medical officer Lesley Russell said. “The When Good Medicines Become Bad Drugs program is part of our continued commitment to patient education to help ensure that prescription medications are used safely and by the appropriate patients.”
The expanded program will include a website, GoodMedicinesBadDrugs.com, which provides videos and other information about prescription drug abuse. According to Cephalon, abuse of prescription drugs now surpasses the use of most illegal drugs. A recent study by the Centers for Disease Control and Prevention showed that emergency room visits related to abuse of prescription drugs more than doubled between 2004 and 2008.