Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) commented on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox® (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application (ANDA). After reviewing the FDA's response to the citizen's petition, which outlines 5 criteria to demonstrate "sameness", Teva believes that it has demonstrated to the FDA that its version of generic Lovenox meets their criteria and that Teva's pending ANDA is approvable... (Source: Health News from Medical News Today)
Posted: 2010-07-27 02:00:00
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