FDA demands more data on Wyeth's Pristiq - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

FDA demands more data on Wyeth's Pristiq - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Wyeth was effectively stiff-armed by the FDA in its application for Pristiq, the first non-hormonal therapy to treat menopausal symptoms. In an approvable letter, regulators told the company that they want to see a one-year safety study done to gather more data on how the drug could affect patients' hearts and livers. That amounts to a major delay for Wyeth, but the drug company shows no sign of backing away from the therapy."