FDA votes against Allergan's Tazoral

The FDA's Dermatologic & Ophthalmic Advisory Committee voted 9-3 against recommending approval of Tazoral oral tazarotene from AGN to treat moderate to severe psoriasis. AGN already markets a topical version of tazarotene, Tazorac, to treat psoriasis and acne. The company said the panel was concerned about potential off-label use of the oral version for acne in pregnant women. In briefing documents, FDA noted that Tazoral caused birth defects in animals.

AGN said other panel concerns included whether there was a suitable risk management program in place for the oral treatment. All three marketed systemic retinoids -- Accutane isotretinoin, Soriatane acitretin and Targretin bexarotene -- have risk management programs in place. ...