This should put to rest the notion that the FDA’s approval of MNTA’s Lovenox was based on favoritism rather than MNTA’s technical superiority.
Amphastar’s ANDA does not (IMO) have what it takes to get FDA approval—ever.
Those on this board who claim that Teva’s ANDA must be credible because it hasn’t been formally rejected by the FDA need look no further than Amphastar to see that an ANDA’s lack of credibility does not necessarily result in a formal rejection.