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Stock Market & Financial Investment News

News Breaks
July 24, 2013
16:00 EDTOPKOPKO citicoline products approved for commercialization in Spain
OPKO Health announced that its Barcelona, Spain subsidiary, Pharmadiet, S.L.U., received regulatory approval from Spains health authority for commercialization of its oral and injectable formulations of citicoline. Final marketing authorization is expected within 60 to 90 days.
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July 28, 2015
13:43 EDTOPKOPKO Health announces FDA acceptance of NDA for Rayaldee
OPKO Health announced that the U.S. FDA has accepted for review OPKOs New Drug Application for calcifediol modified-release capsules, proposed trade name, Rayaldee. In the NDA, OPKO seeks approval of Rayaldee for the prevention and treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. OPKO expects written notification of NDA acceptance along with the Prescription Drug User Fee Act date in the FDAs 74-Day letter, which the company expects to receive by mid-August 2015. The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints, as previously announced.

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