The new dosage will be 0.5mg of norethindrone acetate and 2.5mcg of ethinyl estradiol. This new lower dose is half the dose of the currently marketed Femhrt 1mg/5mcg. Warner Chilcott expects to launch the new low-dose femhrt 0.5mg/2.5mcg in the second quarter of 2005.
For women considering hormone therapy, the American College of Obstetricians and Gynecologists (ACOG) and the FDA have recommended the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual patient. Low-dose Femhrt 0.5mg/2.5mcg provides the “lowest effective dose” of Femhrt.
Commenting on the approval news, Roger Boissonneault, CEO of Warner Chilcott, said: “The new low-dose Femhrt 0.5mg/2.5mcg is an important option for menopausal women and will help to strengthen our presence in the women’s healthcare market. We support the recommendations made by ACOG and the FDA. Low-dose femhrt 0.5 mg/2.5 mcg is consistent with these treatment guidelines.”