MNTA - Court Decision on SNY PI
"Sanofi objects to the FDA's finding that Sandoz' generic has the same active ingredient as Lovenox because it didn't fully analyze the complete structure of the drug. "FDA has determined that parts of Sandoz's product are the same as [Lovenox]. For the rest, FDA is making an assumption," Henn wrote in a brief."
That is one of the reasons the judge needs more time to consider a decision--I think he may need couple months to see if there is any safety issues the mL.
Other than that, I don't see SNY will prevail on this lawsuit against the FDA.
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