Wyeth has submitted reports on two recently completed clinical studies of its osteoporosis drug Viviant to the FDA in support of two new drug applications (NDAs) for the drug.
The agency sent the company an approvable letter for the drug’s proposed prevention indication, requesting data from a Phase III trial, including information on bone fractures.
The data Wyeth submitted come from two trials conducted in Asia. These data also supplement the company’s pending NDA for Viviant (bazedoxifene) to prevent postmenopausal osteoporosis.
The action date for the prevention NDA is the end of this month, but no labeling discussions have taken place yet, the company said. It added that the agency may issue an action letter by the end of the year or extend the review period by 90 days as a result of the new data submission.
The FDA action date for Wyeth’s separate NDA for Viviant as a treatment for postmenopausal osteoporosis remains the end of May 2008, the company said. — Martin Gidron
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