ARTICLE | Company News

Allergan's tazarotene not approvable

September 27, 2004 7:00 AM UTC

AGN received an FDA not approvable letter for its oral tazarotene to treat moderate to severe psoriasis. The company said the letter listed three outstanding issues, including the development of a risk management program, the completion of a non-inferiority study and an FDA deficiency letter regarding manufacturing.

AGN said it is developing a risk management plan, and believes the manufacturing issue is "either resolved or will be resolved shortly." The company said it will work with FDA to clarify the request for a non-inferiority study. ...