Warner Chilcott (LSE:WCRX)
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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/