US firm Allergan says it has a received a non-approvable letter from the US Food and Drug Administration for the use of its oral formulation of Tazorac (tazarotene) in the treatment of psoriasis.
The agency cited a number of issues for its decision, including the completion of a non-inferiority study in severe psoriasis and manufacturing concerns regarding the oral formulation.
Shares in Allergan closed 2.9% lower at $75.64 on September 27, the day of the announcement. Tazarotene, a vitamin A derivative, is already marketed in topical formulations as Tazorac 0.1% for psoriasis and acne and Avage 0.1% for skin damage caused by sun exposure (Marketletters passim).
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