Takeda could see Alogliptin approval in near future
OSAKA, Japan Japanese pharmaceutical manufacturer Takeda’s new diabetes drug could get approval soon, according to Bloomberg.
According to the financial news agency, reports by analysts showed that the drug, alogliptin, had promise after the American Diabetes Association released parts of nine studies of the medication that were submitted for marketing approval in the U.S. in January, last week. They show the drug lowered blood sugar levels as much as Merck’s Januvia without serious side effects.
Alogliptin, also known as SYR-322, will compete with Merck’s Januvia and Novartis’ Galvus, which is also up for approval at the Food and Drug Administration. All three drugs are in a new class of diabetes treatments known as DPP4 inhibitors that signal the pancreas to produce more insulin and the liver to make less glucose, or blood sugar.
Assuming approval by the Food and Drug Administration, Alogliptin will succeed Actos, which generates about 29 percent of Takeda’s current revenue. Actos will lose patient approval in 2011.
FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
FDA issues approvable letter for Wyeth osteoporosis drug
WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.
The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.
Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.