I don't think Amphastar lawsuit has any merit. It does force FDA to respond. FDA doesn't like to be labeled as the appearance of conflict of interest even though being cleared of conflict of interest.
I always thought original murmur about t-enox approval one month after MNTA's had no merit. However, there was merit for murmur on the target date of end of 2010. I believed that was FDA's target timeline for responding to Teva's ANDA. The only reason Teva announced end of January target date was because FDA didn't do it by the end of 2010. It's in the interest of FDA to respond to Teva's ANDA within reasonable time frame of MNTA's approval.
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