FDA issues third approvable letter for Wyeth's bazedoxifene

6/2/2008

WASHINGTON Wyeth Pharmaceuticals’ new drug for treating postmenopausal osteoporosis has hit another speed bump.

The Food and Drug Administration sent a third approvable letter to Wyeth for the drug bazedoxifene pending analyses about the incidence of stroke and venal thrombosis in patients who use it. The FDA made a similar request in a letter sent in December.

Merck reported that its postmenopausal osteoporosis drug Fosamax (alendronate sodium) had worldwide sales of $3.05 billion in 2007.

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