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Article: Allergan Receives Written Response from FDA on Oral Tazarotene.
- Article from:
- Business Wire
- Article date:
- June 1, 2005
CopyrightCOPYRIGHT 2005 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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IRVINE, Calif. -- 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 ...
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