Shire to submit NDA for dry eye treatment
Following a meeting with the FDA last week, Shire has announced that it intends to submit a New Drug Application (NDA) for its dry eye disease treatment, lifitegrast, in the first quarter of 2015, as it completes remaining chemistry and manufacturing work.
Lexington, MA-Following a meeting with the FDA last week, Shire has announced that it intends to submit a New Drug Application (NDA) for its dry eye disease treatment, lifitegrast, in the first quarter of 2015, as it completes remaining chemistry and manufacturing work.
“As we prepare for the FDA submission, we will also form an ophthalmic business unit that will focus on the commercialization of our ophthalmic pipeline products,” aid Flemming Ornskov, MD, chief executive officer of Shire.
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