I guess it‘s protocol. The same protocol that states that you need to list side-effects probably says if your side-effect list is wrong you have to re-list and

I guess it‘s protocol. The same protocol that states that you need to list side-effects probably says if your side-effect list is wrong you have to re-list and get approved again. Until your approval is not done you don‘t get to sell. Otherwise you could delay your updating your side-effects listing because you know FDA will take your druf off-market (and this delay will/could cause harm to people).