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Allergan Inc. (AGN) Demands the FDA Require Human Trials for Restasis Generics


8/21/2013 7:23:20 AM

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Allergan Inc. has asked the U.S. Food and Drug Administration to revise the agency's draft guidelines for firms seeking to produce generic versions of its chronic dry eye disease treatment, Restasis. In a 43-page letter posted to the company's website, Allergan called for the FDA to require human clinical studies of generics to prove their comparability, instead of the current draft's recommendation for in vitro, or laboratory, analyses alone. The company's response sent shares rising 3.9% to $92.23 in recent trading, earlier touching a high of $93.25.

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