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Shire says FDA declines to approve eye drug Lifitegrast

2015-10-17 08:11:06| Biotech - Topix.net

The U.S. Food and Drug Administration notified Shire Plc it will not approve its eye drug Lifitegrast, the company said on Friday, adding that the U.S. health regulator recommended the company conduct additional clinical studies. The news comes over a week before the FDA was supposed to make a decision on Lifitegrast on Oct 25. Shire said it received a complete response letter, which the FDA sends to let a drug developer know a marketing application will not be approved in its present form.

Tags: eye drug approve fda

Category:Biotechnology and Pharmaceuticals

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