FDA grants tentative approval for Teva’s generic Aricept
JERUSALEM The Food and Drug Administration has granted tentative approval to Teva for its application to market a generic version of Eisai’s Alzheimer’s drug Aricept (donepezil hydrochloride).
Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of New Jersey involving Teva’s paragraph IV certification to U.S. Patent No. 4,895,841. Although a trial date has not been set, the court has set a briefing schedule for a preliminary injunction motion under which Eisai must file its request no later than Feb. 15. Final approval of this application is anticipated on or about April 26.
The drug, if approved, will be available in 5 mg and 10 mg tablets. The brand drug had annual sales of approximately $1.6 billion in the U.S. for the 12 months that ended Sept. 30, 2007, based on IMS sales data.
FDA to open office in India
KOCHI The Food and Drug Administration is planning on opening an office of its agency in India, in an effort to ensure the quality of the food and drugs being imported by the U.S., according to published reports.
Health and Human Service secretary Michael Leavitt and FDA commissioner Andrew von Eschenbach are in the country presently assessing the manufacturing practices existing at drug and food processing units.
According to Leavitt, he set up the mission because, “there was a serious apprehension among the consumers in this country on the quality of food and drugs being imported.” “We are trying to ensure the quality in the entire system of supply chain, right from the seed to the last outlet from where people buy the goods,” he said.
The U.S. imports about $56 million worth of food and drug products from India.
BioDelivery works on risk management plan for dissolving fentanyl patch
RALEIGH, N.C. BioDelivery Services International is planning on developing a safety plan for its new BEMA fentanyl patch, which the Food and Drug Administration accepted for review last week, according to published reports.
In December, a public health advisory from the FDA was released following reports of life-threatening side effects and even death associated with inappropriate prescriptions or use of the patches. So, to be safe, BioDelivery has developed a Risk Minimization Action Plan, or RiskMap, for its patch, which dissolves in the mouth and is placed on the walls of the cheek, unlike other fentanyl patches, which are placed on the skin and have to be disposed of.
Fentanyl is a narcotic pain medication more powerful than morphine. It has been in use for years. The FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.
BioDelivery’s vice president of marketing stated that the company is more confident as to the differences between its patch and other fentanyl patches, and believes the confidence is extended to how the drug is meant to be used and how the drug is delivered in the body.