TazaroteneTreatment for Psoriasis
Allergan Receives Written Response from FDA on Oral Tazarotene
IRVINE, Calif., June 1, 2005 - Allergan, Inc. (NYSE:AGN) today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding Allergan's request for formal dispute resolution on its oral tazarotene capsule New Drug Application (NDA). In the response, the FDA outlined multiple potential options for improving oral tazarotene's risk-benefit profile. Allergan currently believes it can fund a pivotal clinical trial requested by the FDA and complete the study in a reasonable amount of time. Allergan also plans to provide some additional pharmacokinetic and toxicology data to the FDA.
"We appreciate the FDA's willingness to work with Allergan to explore the clinical data necessary for approval and we are encouraged to have defined potential pathways to approval for oral tazarotene," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research and Development. "We remain committed to providing oral tazarotene to psoriasis patients."
Based on the FDA's recommendations, Allergan plans to submit a development plan to the FDA and will provide details on the plan once an agreement has been reached with the FDA.
Posted: June 2005