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News Breaks
February 16, 2014
16:53 EDTJNJFDA issues CRLs for Johnson & Johnson's sNDAs for use of Xarelto
On Friday morning, Johnson & Johnson unit Janssen Research & Development announced the U.S. Food and Drug Administration issued complete response letters, CRLs, regarding supplemental New Drug Applications, sNDAs, for the use of Xarelto, rivaroxaban, an oral anticoagulant, to reduce the risk of secondary cardiovascular events -- defined as heart attack, stroke or death -- in patients with acute coronary syndrome, ACS, and to reduce the risk of stent thrombosis in the same population, in combination with standard antiplatelet therapy. "We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events," said Paul Burton, M.D., Ph.D., Vice President, Clinical Development, Janssen Research & Development. "We are evaluating the contents of the letters and will determine the appropriate next steps."
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July 27, 2015
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July 23, 2015
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
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10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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