You are here

Non-Approvable Letter Issued for Tazarotene Capsules

IRVINE, Calif., Sep 27, 2004 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter for tazarotene capsules (oral tazarotene) for the treatment of psoriasis.

In addition to other questions posed, the FDA's letter listed three non-approvability issues for oral tazarotene for the treatment of psoriasis:

-- 1. The development of an acceptable risk management program. Allergan is in the process of developing an appropriate risk management plan.

-- 2. Completion of a non-inferiority study in severe psoriasis. Allergan will work with the FDA to clarify this request.

-- 3. Satisfaction of an FDA deficiency letter regarding the manufacture of the oral tazarotene capsules. Allergan believes this issue is either resolved or will be resolved shortly to the FDA's satisfaction.

"The FDA has invited Allergan to request a meeting to work through the open issues regarding oral tazarotene, which we will do," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research and Development. "Allergan will continue to work with the FDA toward our goal of bringing oral tazarotene to patients suffering from psoriasis."

Source: Allergan

Recent Headlines

Averts Disease Worsening, Reduces Potential for Blindness
Risk May Remain for 6 Months After Treatment
FDA Removes Boxed Warning With Drug’s Fifth Approval
Overeager Use of Recommendations Creates Problems
Artificial Intelligence Enables Platform to Detect Amyloid PET Status
Kadcyla Cut Risk of Recurring Disease by Half Compared to Herceptin
May Lead to Personalized Treatment for Schizophrenia, Other Illnesses
First Medicines for Adults With Wild-type or Hereditary ATTR-CM