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Allergan, Inc.
Allergan Receives Complete Response Letter for BOTOX® Botulinum Toxin Type a for Treatment of Upper Limb Spasticity in Adults
June 12th, 2009
Allergan, Inc. (NYSE:AGN) announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s Supplemental Biologics License Application (sBLA) for BOTOX® (Botulinum Toxin Type A) to treat upper limb spasticity in post-stroke adults. Allergan submitted its sBLA for this indication in the third quarter of 2008. The FDA has not requested additional pre-approval clinical studies. However, the FDA has identified items that must be completed before the sBLA can be considered for approval, including the following: 1. Risk Evaluation and Mitigation Strategy (REMS) and Safety Update: On April 29, 2009, the FDA approved...
Source: Health Business Week (2009-06-12)
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