FDAnews Drug Daily Bulletin

The FDA approved Leo Pharma’s Taclonex Scalp for the treatment of moderate-to-severe plaque psoriasis of the scalp.

Warner Chilcott, which holds an exclusive license to market the topical drug, plans to launch Taclonex Scalp (calcipotriene/betamethasone dipropionate) during the second half of 2008, the company said. The product is a combination of a vitamin D analogue and a corticosteroid. The FDA’s approval triggers a $40 million milestone payment from Warner Chilcott to Leo Pharma.

The FDA approved Taclonex ointment to treat plaque psoriasis in early 2006. The ointment had sales of $37 million during the first quarter of 2008.

The approval is good news for the Leo Pharma-Warner Chilcott partnership, which covers both Taclonex brands and Dovonex. A generic version of Dovonex (calcipotriene) entered the market in May, Chilcott said. Sales for the brand product, which is a component of Taclonex, fell 20 percent to $33 million during the first quarter of 2008.