Osteoporosis

Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis

Published in Law and Health Weekly, May 12th, 2007

Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis.

"The approvable letter for bazedoxifene is in line with our expectations, and we are pleased to stay on track with our plans to introduce this new osteoporosis therapy," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for...

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Source: Law and Health Weekly (2007-05-12)

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