Warner Chilcott secures FDA approval for Femtrace

ISEQ, FTSE and Nasdaq-listed Warner Chilcott has secured approval from the US Food & Drug Administration (FDA) for Femtrace™ tablets for the relief of the vasomotor symptoms (eg hot flashes, flushing) of menopause.

Warner Chilcott PLC is a specialty pharmaceutical company focused on two core therapeutic areas: women’s healthcare and dermatology.

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.

Warner Chilcott was originally founded in 1968 as a sales and marketing organisation focused on branded pharmaceutical products in the UK and Republic of Ireland