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Hawk_Driver

04/23/20 3:05 PM

#268545 RE: ORBAPU #268537

Ah I see your point. I agree should, but not too confident about the would. It’s an interesting thought that a generic label should warn against prescription for CVD. I can almost imagine that prescribers might be dissuaded from off-label prescriptions based on fears of malpractice.

Of course then there’s a new issue: what happens when the reduce-it patents expire? FDA might be in a precarious position in 2030 when generics seek entry to the broader market.