Warner Chilcott is planning an early 2005 launch for Femtrace (estradiol acetate) in three dosage strengths, 0.45 mg, 0.9 mg and 1.8 mg, the company said.

FDA approved Femtrace tablets Aug. 20 for relief of the vasomotor symptoms of menopause, but not for a secondary indication in the treatment of vulvar-vaginal atrophy.

Femtrace's competition will include Wyeth's estrogen-only hormone replacement therapy market leader, Premarin (conjugated estrogens).

Sales for the Premarin hormone franchise have been declining. Wyeth is initiating a direct-to-consumer advertising campaign in an effort to stabilize sales (¹ Also see "Wyeth Premarin DTC Campaign Aims To Reduce Losses" - Pink Sheet, 21 July, 2004.).

Warner Chilcott will market Femtrace using part of its 400-person U.S. sales force, the company said.

The firm manufactures three additional hormone replacement therapy products: Estrace (estradiol), FemHRT (ethinyl estradiol) and Femring (estradiol acetate).

Warner Chilcott anticipates two additional approvals in the first half of next year.

Applications are pending at FDA for FemHRT Lo , a low-dose version of FemHRT, and a line extension to the antibiotic Doryx (doxycycline) for the treatment of acne, with user fee dates in January and February, respectively.

Femtrace's NDA (21-633) was received by FDA Oct. 20, 2003. [Editor's note: this story previously contained the wrong submission date. A ² Also see "Warner Chilcott Femtrace (Correction)" - Pink Sheet, 25 August, 2004. was published Aug. 25.]

Launch of Warner Chilcott's chewable oral contraceptive, Ovcon 35 , has been delayed due to manufacturing difficulties at Bristol-Myers Squibb (³ Also see "Warner Chilcott Ovcon 35 Launch Delayed By Bristol Manufacturing" - Pink Sheet, 12 August, 2004.).

- Andrew Shelton

Femtrace Launch Planned For Early 2005

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