Friday, July 26, 2013 3:07:52 PM
Regarding MYL’s ANDA, I have no insights other than to note that MYL acquired the product from India’s Natco, where approval standards for FoB’s are relatively low.
The problem is that the FDA rarely rejects a generic but rather just lets them collect dust in a corner. It'll be a cloud over generic copax no matter what happens.
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