Law360, New York (February 07, 2012, 5:24 PM ET) -- A Washington federal judge found Tuesday that the U.S. Food and Drug Administration was within its rights to ask for additional information before approving a generic version of Sanofi-Aventis SA's anti-clotting drug Lovenox.
U.S. District Judge Amy Berman Jackson granted the FDA's cross-motion for summary judgment, finding that the agency did not exceed its statutory authority by asking intervenor-defendant Sandoz Pharmaceutical Industries Inc. for immunogenicity data regarding the potential risk of generic Lovenox causing an adverse immune response.
“Because FDA’s request for immunogenicity data in Sandoz’s...
Judge Upholds FDA Approval Of Generic Lovenox
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