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Galen Femring approved

Executive Summary

Galen Femring (estradiol acetate) to launch in U.S. market in June following FDA approval March 20. The hormone therapy is second approved since FDA halted the Women's Health Initiative study in July 2002. Femring labeling follows Wyeth's template, including "black box" warning of increased incidence cardiovascular disease and breast cancer with long-term use (1"The Pink Sheet" Jan. 13, p. 21). Femring will be available in two doses, .05 mg/day or .1 mg/day, with each ring delivering estrogen over a three-month period...

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