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FDA requests additional clinical study in complete response letter to lifitegrast NDA
The FDA requested an additional clinical study in a complete response letter regarding the new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults, according to a press release from Shire. “We will work quickly to address the FDA’s requests related to lifitegrast, as we are committed to delivering a new prescription treatment option for the 29 million adults in the U.S. living with symptoms of this chronic and progressive disease,” Philip J. Vickers, PhD, head of research and development of Shire, said in (Read more...)