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FDA Approves Taclonex

FDA Approves Taclonex - Once Daily Therapy for Treatment of Psoriasis

January 11, 2006 - Warner Chilcott and LEO Pharma announced 10 January 2006 that 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 1 January 2006 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.

Warner Chilcott is a U.S. specialty pharmaceutical company focused on marketing, developing and manufacturing branded prescription pharmaceutical products in dermatology and women’s healthcare.


Warner Chilcott’s Forward Looking Statements
This press release contains forward-looking statements, including statements concerning our operations, our economic performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “may,” “might,” “will,” “should,” “estimate,” “project,” “plan,” “anticipate,” “expect,” intend,” “outlook,” “believe” and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. For a discussion of these risk and uncertainties, see our quarterly reports to the holders of the 8-3/4% Senior Subordinated Notes due 2015 (the “Notes”) issued by the Company’s affiliate, Warner Chilcott Corporation. These documents and other information are available upon request at no cost, by sending a request by email to or by mail to 100 Enterprise Drive, Rockaway, New Jersey, 07866, Attention: Beth Kozinski.

Posted: January 2006

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Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

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