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FDA acknowledges receipt of Shire’s resubmitted NDA for lifitegrast

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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.

“The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22, 2016,” the release said.

The NDA now includes data from a phase 2 study, the OPUS-1, OPUS-2 and OPUS-3 phase 3 safety and efficacy studies, and the phase 3 SONATA safety study.

Shire originally submitted the NDA in February 2015. The FDA granted priority review designation for lifitegrast in April 2015. The designation accelerated the review target to 8 months rather than 12 months, the release said.