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FDA Approves Taclonex® - Once Daily Therapy for Treatment of Psoriasis
The United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Taclonex®. LEO Pharma submitted the NDA for Taclonex® to the FDA in March 2005. Taclonex® is a topical ointment containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of psoriasis vulgaris in adults. Taclonex® is sold outside the U.S. as Dovobet® or Daivobet®.
Warner Chilcott acquired the U.S. marketing rights for Dovonex® (calcipotriene 0.005%), the leading non-steroidal topical treatment for psoriasis in the U.S., from Bristol-Myers Squibb Company as of January 1. Warner Chilcott is now LEO Pharma’s exclusive licensee of Taclonex® and Dovonex® in the United States. Warner Chilcott expects to launch Taclonex® in the first half of 2006.
“Taclonex® presents an exciting proposition for the treatment of psoriasis in the U.S., and we are preparing for its launch with great anticipation,” said Roger Boissonneault, CEO of Warner Chilcott.
Psoriasis is a chronic, inflammatory skin disease for which there is no cure. In plaque psoriasis (psoriasis vulgaris), the most common type, patches of skin called “lesions” become inflamed and are covered by silvery white scale. A non-contagious disorder, psoriasis can occur on any part of the body, and can significantly alter a sufferer’s life both physically and mentally, including the ability to work, play and interact with others. More than 4.5 million adults in the United States have been diagnosed with psoriasis, and approximately 150,000 new cases are diagnosed each year.
New Oral Contraceptive Approved by FDA
First Birth Control Pill to Provide 24 Days of Active Hormonal Therapy
Warner Chilcott announced today that the U.S. Food and Drug Administration (FDA) has approved it’s 24-day oral contraceptive, Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), for the prevention of pregnancy. Loestrin 24 Fe (“Loestrin 24”) is the first birth-control pill approved in the United States that provides 24 days of active hormonal therapy and four days of iron containing placebo pills.
“This FDA approval is a significant step forward for Warner Chilcott as we continue to sharpen our therapeutic focus on women’s health and expand our product portfolio in this area,” said Roger Boissonneault, Chief Executive Officer of Warner Chilcot.
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