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Warner Chilcott Announces Approval of Low-Dose femhrt® 0.5 mg/2.5 mcg
ROCKAWAY, NJ -- January 17, 2005 -- Warner Chilcott announced today that the Food and Drug Administration (FDA) has approved low- dose femhrt® 0.5 mg/2.5 mcg for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.
The new dosage will be 0.5 mg of norethindrone acetate and 2.5 mcg of ethinyl estradiol. This new lower dose is half the dose of the currently marketed femhrt® 1 mg/5 mcg.
The company expects to launch the new low-dose femhrt® 0.5 mg/2.5 mcg in the second quarter of 2005.
For women considering hormone therapy, the American College of Obstetricians and Gynecologists (ACOG) and the FDA recommend the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman. Low-dose femhrt® 0.5 mg/2.5 mcg provides the "lowest effective dose" of femhrt®.
Commenting on today's news, Roger Boissonneault, CEO of Warner Chilcott, said: "The new low-dose femhrt® 0.5 mg/2.5 mcg 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. My congratulations go to all those colleagues who contributed to this important project."
SOURCE: Warner Chilcott
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