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.