Lovenox Generics: FDA’s Split Opinion On ANDA Approval Fully Supported By Court
By
Brenda Sandburg / Email the Author / “The Pink Sheet” DAILY Feb. 7, 2012
Word Count: 884 / Article # 14120207007
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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