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

 
• By Brenda Sandburg

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.

FDA’s standards for approving a generic version of Sanofi’sLovenox (enoxaprin) were upheld by a federal court decision dismissing Sanofi’s suit against the agency.

In a Feb. 7 opinion, U.S. District Judge Amy Jackson of the District of Columbia found the agency acted properly in approving Sandoz’s enoxaparin ANDA

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More from North America

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• By Derrick Gingery

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