Biotech Values

[exwannabe]

Re: MNTA's confidential data.

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.