Amarin Corp Plc (AMRN)

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An FYI
Veloxis Pharmaceuticals A/S (CSE:VELO) filed suit in the U.S. District Court for the District of Columbia seeking an order requiring FDA to grant final approval to immunosuppressant Envarsus XR tacrolimus and allow Envarsus XR to be immediately approved for sale in the U.S.
In October, FDA sent Veloxis a tentative approval letter for once-daily Envarsus XR, which delayed final marketing approval until exclusivity expires for once-daily Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503) on July 19, 2016 (see BioCentury Extra, Oct. 31).
According to the suit, Veloxis believes Astagraf XL is not entitled to exclusivity and that FDA's failure to immediately approve Envasus XR exceeds its statutory authority. Specifically, Veloxis argues Astagraf XL did not meet the statutory test for exclusivity for antibiotic-containing compounds based on the date Astellas submitted in its NDA.
Veloxis is seeking an injunction ordering FDA to rescind the marketing exclusivity awarded to Astagraf XL.
Envarsus XR is approved in Europe, where partner Chiesi Farmaceutici S.p.A. (Parma, Italy) has commercialization rights. The product delivers tacrolimus using Veloxis' MeltDose technology.
Veloxis fell DKK0.04 to DKK1.12 on Tuesday. B