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FDA Approves Femtrace (Estradiol Acetate) Treatment for Vasomotor Symptoms of Menopause
CRAIGAVON, NORTHERN IRELAND, and ROCKAWAY, NJ -- August 23, 2004 -- Warner Chilcott PLC ("Warner Chilcott") (Nasdaq: WCRX)(LSE: WCRX), announced today that the U.S. Food & Drug Administration (FDA) has approved Femtrace™ tablets for the relief of the vasomotor symptoms of menopause. An approval was not granted for the secondary indication of vulvar-vaginal atrophy. The New Drug Application (NDA) for Femtrace was accepted for filing on December 19, 2003. All dosage strengths, i.e. 0.45 mg, 0.9 mg and 1.8 mg of estradiol acetate were approved. The Company expects to launch Femtrace in the first quarter of 2005.
Femtrace is the first approval of three applications currently filed with the FDA. Approvals for femhrt®LO, a low-dose version of femhrt®, a combined oral estrogen-progestogen product, and a line extension to Doryx®, a tetracycline antibiotic for the treatment of acne, are expected in the first half of next year.
Commenting on today's news, Roger Boissonneault, CEO of Warner Chilcott, said: "We welcome the approval of Femtrace. This is the first of a series of new products either currently filed with the FDA or due to be submitted in 2005. These products will help strengthen our presence in women's healthcare and dermatology and will drive future growth of Warner Chilcott past the end of this decade. My congratulations go to all those colleagues who contributed to this important project."
For further information on Warner Chilcott visit: http://www.warnerchilcott.com
SOURCE: Warner Chilcott PLC
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