Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment
OSAKA, Japan--(BUSINESS WIRE)--The U.S. FDA has accepted Santen's NDA for intravitreal (IVT) sirolimus (440 µg) for the treatment of non-infectious uveitis of the posterior segment. The PDUFA action date is December 24, 2017.