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Warner Chilcott and Leo Pharma obtain FDA approval for Taclonex Scalp

Warner Chilcott and Leo Pharma have announced that the FDA has approved the new drug application for Taclonex Scalp topical suspension for the treatment of moderate to severe psoriasis vulgaris of the scalp in adults.

Taclonex Scalp (calcipotriene 0.005% and betamethasone dipropionate 0.064%) is called Xamiol outside the US.

Warner Chilcott is Leo Pharma’s exclusive licensee of Taclonex and Dovonex products in the US. Warner Chilcott expects to launch Taclonex Scalp in the second half of 2008. As a result of the FDA approval of Taclonex Scalp, Warner Chilcott will pay a milestone payment of $40 million to Leo Pharma in June 2008.

Roger Boissonneault, CEO of Warner Chilcott, said: “Taclonex Scalp represents an exciting addition to our Taclonex and Dovonex franchise, expanding the treatment options for psoriasis patients in the US.”