Press Release Source: Teva Pharmaceutical Industries Ltd. On Friday July 23, 2010, 2:33 pm JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA - News) commented today 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.
Teva maintains the approval for an ANDA for generic Lovenox is appropriate because: - The active ingredient in enoxaparin is significantly better characterized than the active ingredients of significantly more complex molecules - Pharmacologically active portions of enoxaparin can be identified and replicated, and - In vitro and in vivo PD tests are rapidly indicative of drug efficacy and safety
Teva recognizes and supports FDA authority and discretion to make generic drug approvals on a case-by-case basis considering drug complexity, patient efficacy and safety outcomes.
Given the complexity of Teva’s Copaxone® and the serious, degenerative nature of multiple sclerosis, it is Teva’s belief that any potential generic version of Copaxone should be evaluated via pre-clinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in multiple sclerosis patients to establish safety, efficacy and immunogenicity in a real patient population.
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