U.S., European diabetes associations update their treatment guidelines
NEW YORK The American Diabetes Association and the European Association for the Study of Diabetes updated their treatment guidelines for Type 2 diabetes Wednesday and listed as a secondary treatment option for patients the class of drugs that includes Eli Lilly’s and Amylin Pharmaceuticals’ Byetta.
Byetta is the only drug in a class known as GLP-1 analogs on the market, though Novo Nordisk is developing GLP-1 analog liraglutide. It has faced safety concerns lately as six diabetes patients taking it have died, though the deaths have not been directly linked to the drug.
Still, the two organizations’ listing of the drug as a diabetes treatment could increase sales. A twice-daily injection, it is known generically as exenatide.
FDA launches new Web page to provide safety information on prescription drugs
WASHINGTON The Food and Drug Administration announced Wednesday that it had launched a Web page to provide consumers and healthcare professionals with a single source of safety information about prescription drugs.
The page, www.fda.gov/cder/drugsafety.htm, provides links to information in categories such as drug labeling, drugs with risk evaluation and mitigation strategies, regulations and guidance documents and warning letters, import alerts, recalls, market withdrawals and safety alerts.
“By placing Web links to these up-to-date resources on a single page, we’re helping consumers and healthcare professionals find drug safety information faster and easier,” said Dr. Paul Seligman, associate director of safety policy and communication in the FDA’s Center for Drug Evaluation and Research. “This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use.”
FDA approves generic version of Epivir
WASHINGTON The Food and Drug Administration has granted tentative approval to Indian drug maker Macleods Pharmaceuticals’ generic version of GlaxoSmithKline’s HIV drug Epivir (lamivudine), FDA records show.
The drug would be available as 150 mg and 300 mg tablets, but cannot be marketed in the United States because of patent protection.
GSK’s patent for lamivudine will expire in 2010. Epivir had sales of $246.85 million in 2007, according to GSK financial records.