Allergan Inc has been issued a non-approvable letter for tazarotene capsules (oral tazarotene) by the US Food and Drug Administration (FDA) for the treatment of psoriasis.
In addition to other questions posed, the FDA's letter listed three non-approvability issues - The development of an acceptable risk management programme; Completion of a non-inferiority study in severe psoriasis; Satisfaction of an FDA deficiency letter regarding the manufacture of the oral tazarotene capsules-for oral tazarotene for the treatment of psoriasis, the company release says.
"The FDA has invited Allergan to request a meeting to work through the open issues regarding oral tazarotene, which we will do," Dr. Scott Whitcup, Allergan's executive vice president, Research and Development said adding, "Allergan will continue to work with the FDA toward our goal of bringing oral tazarotene to patients suffering from psoriasis."
Allergan Inc, with headquarters in Irvine, California, is a health care company which develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets.