FDA demands more data on Wyeth's Pristiq

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.

"Wyeth remains committed to the development of Pristiq as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause," said Wyeth CMO Dr. Gary Stiles. "We will work with the agency, and we have not yet met with them, to satisfy its requests for additional data and move this medicine forward in the FDA review process."

- see the release [1]
- check out the AP report [2] for more

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