Warner Chilcott PLC announced that the US 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, an official release said.
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, the release added.
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."
Warner Chilcott also confirmed that, following recent meetings with LEO Pharma S/A (LEO), it is expected that an NDA for Dovobet, a combination of calcipotriene and betamethasone dipropionate, will be filed by March 2005. Dovobet is indicated for the treatment of psoriasis. Under the terms of a Master Agreement dated April 1, 2003, Warner Chilcott has agreed to license Dovobet from LEO upon marketing approval of the product for the US market. Dovobet has been approved and is currently marketed in at least 23 countries worldwide.
The Company has decided to discontinue its programmes to develop a metronidazole vaginal ring to treat bacterial vaginosis and a fluconazole vaginal ring for candidiasis.