Warner-Lambert Femhrt
Executive Summary
Norethindrone acetate/ethinyl estradiol tablets approved Oct. 15 in a 1/5 dose for the treatment of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis in women with an intact uterus. FDA rejected an application for the higher 1/10 dose of Femhrt, noting that "optimally, drugs used to prevent osteoporosis are administered at the lowest effective dose." Warner-Lambert plans to launch the product by the end of the year