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FDA acknowledges receipt of Shire’s resubmitted NDA for lifitegrast
The FDA has acknowledged receipt of a new drug application resubmitted by Shire for lifitegrast to treat signs and symptoms of dry eye disease, the company announced in a press release.Shire resubmitted the application in response to a complete response letter in which the FDA requested an additional clinical study and more information on product quality, the release said.