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Stock Market & Financial Investment News

News Breaks
November 29, 2012
05:55 EDTOPK, OPK, OPK, OPKOPKO Health management to meet with Barrington
Meetings to be held in Kansas City on December 4, in Montreal on December 5 and in Toronto on December 6 hosted by Barrington.
News For OPK From The Last 14 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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