Court Backs FDA Rationale For Approving Generic Lovenox
Executive SummaryA district court shot down Sanofi-Aventis' arguments against FDA approval of Sandoz's generic Lovenox (enoxaparin)
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The decision will give FDA ammunition for future battles over biosimilar approvals as Sanofi’s suit against the agency is tossed out. The court notes there was a split within FDA over its five-pronged test for active ingredient sameness, which the judge sees as evidence that the issues were carefully weighed.