An ANDA inherently relies on confidential data. If S-A had never provided confidential Lovenox data to the FDA, obviously the MNTA generic could not be approved.
But this is done in accordance with the statute, so it is legal.
S-A is arguing that by not acting in accordance with the statute the FDA misused the S-A confidential data.
This is not the basis of the reason the argument that the FDA could not approve, it is the basis for damage to S-A that gives them standing to sue.
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