FDA Again Rejects J&J, Bayer Blood Thinner Expansion

Law360, Washington (February 14, 2014, 6:40 PM EST) -- The U.S. Food and Drug Administration refused for the third time to expand use of Johnson & Johnson and Bayer AG’s blood thinner Xarelto to include treatment of acute coronary syndrome, the drugmakers said on Friday.

J&J’s Janssen Research & Development LLC unit received a complete response letter from the regulator denying the request, but neither drugmaker would comment on whether FDA wanted additional information or clinical trials before approving the expanded use.

“We are disappointed with the outcome of the review and together with our...
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