The Federal Drug Administration (FDA), in its letter to Wyeth—the manufacturer of the menopause Pill Pristiq—has outlined the need to perform at least one more year of clinical tests on the drug before it is aproved.
The FDA has called for more data on how Pristiq affects the heart and liver health of patients.
Wyeth, which is the largest manufacturer of hormone treatments today, has developed Pristiq to control menopausal symptoms such as night sweats and hot flashes and has forecast an annual revenue of $2 billion from the drug.
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