Specifically, in the case of FDA’s approval of generic menotropins drug products, the key issue was whether a non-fully characterized brand product could be insulated from generic competition because it was not fully characterized. FDA and the courts ultimately and conclusively ruled that for products such as menotropins (and enoxaparin here), the lack of full characterization is not a barrier to ANDA approval
Has this prior approval been discussed here as regards the menotropins and why that would be precedent in the case of lovenox or other generics?
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