Lupenox is not low-quality; to the contrary, it probably works as well as any other low-molecular-weight heparin drug in the medical indications where such drugs are used. If a company submitted a Lupenox NDA (rather than an ANDA), it could likely obtain FDA approval for Lupenox as a new branded drug.
But the topic of this discussion is not a new branded drug—it’s an application to the FDA for a generic version of Lovenox. For this, merely being a safe and effective LMWH drug is not sufficient; to be approved, the drug in question must satisfy the FDA’s requirements for sameness to branded Lovenox.
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