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Re: tekcor_atnm post# 107286

Tuesday, 10/26/2010 9:09:11 PM

Tuesday, October 26, 2010 9:09:11 PM

Post# of 257253
Re: MNTA "I think it is also interesting that in fighting the Amphastar lawsuit the FDA ends up defending Momenta's superiority"

It is the Sanofi suit that has helped MNTA for this reason.

The FDA has responded to it by establishing the strongest possible standards that mL met. This was of course what Sandoz/MNTA had offered as justification of their ANDA.

So before the suits the FDA had wiggle room to go with an easier standard for TEVA, they now will be forced to stick with the letter of their own position.

Actually, this benefits S-A also (they are doing fine under the new status-quo). Possibly a side motive for the suit?

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