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Shire says U.S FDA declines to approve eye drug Lifitegrast

Reuters - UK Focus

Oct (HKSE: 3366-OL.HK - news) 16 (Reuters) - The U.S (Other OTC: UBGXF - news) . Food and Drug Administration notified Shire Plc (Xetra: S7E.DE - news) it will not approve its eye drug Lifitegrast, the company said on Friday, adding that the U.S. health regulator recommended the company conduct additional clinical studies.

Shire said it received a complete response letter, which the FDA sends to let a drug developer know a marketing application will not be approved in its present form.

Shire had submitted a marketing application for the drug in treating patients with dry eye disease, the company said in a statement.

A decision on the drug's approval was expected by October 25. (Reporting by Rosmi Shaji in Bengaluru; Editing by David Gregorio)