Warner Chilcott and Leo Pharma received an approval from the US Food and Drug Administration for the new drug application (NDA) for Taclonex.
According to a company release, 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 US as Dovobet or Daivobet.
Warner Chilcott acquired the US marketing rights for Dovonex (calcipotriene 0.005%), the leading non-steroidal topical treatment for psoriasis in the US, from Bristol-Myers Squibb Company as of January 1. Warner Chilcott is now Leo Pharma's exclusive licensee of Taclonex and Dovonex in the US. Warner Chilcott expects to launch Taclonex in the first half of 2006.
"Taclonex presents an exciting proposition for the treatment of psoriasis in the US, 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.
Leo Pharma is a research based pharmaceutical company in topical dermatology and parenteral treatment of thromboembolic disorders.