Judge Upholds FDA Approval Of Generic Lovenox

Law360, New York (February 7, 2012, 5:24 PM EST) -- 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...
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Case Information

Case Title

SANOFI-AVENTIS U.S. LLC v. FOOD AND DRUG ADMINISTRATION et al


Case Number

1:10-cv-01255

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Amy Berman Jackson

Date Filed

July 26, 2010

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