Wyeth to re-submit Viviant this year, expects advisory committee review
This article was originally published in Pharmaceutical Approvals Monthly
Wyeth plans to resubmit its osteoporosis drug Viviant (bazedoxifene) this year, and given the drug's safety concerns, the firm is expecting an FDA advisory committee review to follow. The selective estrogen receptor modulator has received two "approvable" letters since the initial NDA submission, with FDA requesting more information on the incidence of stroke and VTE. Even still, execs said in a March 17 presentation at the Cowen Health Care Conference that they are "pleased" with the drug's clinical profile. Wyeth also expects an approval decision for Viviant in Europe shortly, where it recently received a positive opinion
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