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Lovenox Generics: FDA’s Split Opinion On ANDA Approval Fully Supported By Court

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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