Drug news
Shire announced planned filing at FDA of lifitegrast for Dry Eye Disease in first quarter 2015.
Following a May 15, 2014, meeting with the FDA, Shire plc , announced that it intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of Dry Eye Disease in adults in the first-quarter 2015, as Shire completes remaining chemistry and manufacturing work. In parallel to preparing for the NDA submission, Shire will be assessing the need for gathering additional clinical data in support of the U.S. and potential international regulatory submissions.
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