Warner Chilcott Announces Approval of Low-Dose femhrt(R) 0.5 mg/2.5 mcg
18 January 2005 - 12:00AM
PR Newswire (US)
Warner Chilcott Announces Approval of Low-Dose femhrt(R) 0.5 mg/2.5
mcg ROCKAWAY, N.J., Jan. 17 /PRNewswire-FirstCall/ -- Warner
Chilcott announced today that the Food and Drug Administration
(FDA) has approved low- dose femhrt(R) 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(R) 1 mg/5 mcg. The company expects to
launch the new low-dose femhrt(R) 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(R) 0.5 mg/2.5 mcg provides the "lowest effective
dose" of femhrt(R). Commenting on today's news, Roger
Boissonneault, CEO of Warner Chilcott, said: "The new low-dose
femhrt(R) 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(R) 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." For further information
on Warner Chilcott, visit: http://www.warnerchilcott.com/
DATASOURCE: Warner Chilcott CONTACT: James P. Chirip, Director of
Marketing of Warner Chilcott, +1-973-442-3328 Web site:
http://www.warnerchilcott.com/
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