n sleven, yes I understand if they have 180 days to launch that would bring them into the end of feb approx. Maybe FDA has correspondence but hasn't made it public. I'll keep searching.
n sleven, dr. reddy doesn't have icosapent ethyl listed as one of their generic drugs on their website. On the FDA website it states label not available????? What am I missing? Then in the second link the #A209499 is not interactive?
In order to keep the ANDA FDA required an explanation as to why the launch didn't happen on time
What makes you think that? Don't confuse the 1st ANDA filer having to launch within a 180 window of exclusivity with an approved ANDA have to launch, period, or FDA withdraws the ANDA - FDA cannot make business decisions for generics.
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