Hi-Tech: Tentative OK on Generic Dovonex
March 23, 2007
U.S. firm Hi-Tech Pharmacal said Friday it has tentative approval to market a generic version of Warner Chilcott’s topical drug Dovonex.
The Food and Drug Administration has tentatively cleared for market the company’s Abbreviated New Drug Application for calcipotriene topical solution, 0.005 percent, indicated for the treatment of psoriasis of the scalp.
Hi-Tech estimated 2006 sales of the branded drug at $13 million, based on data from IMS Health.
The FDA’s full approval must await expiration of the patent covering Dovonex, which is due to expire Dec. 29, the company said.