FDA News

FDA Response to Citizen Petition Announced by Teva Pharmaceutical Industries

(March 26, 2009) -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the Food and Drug Administration has responded to their Citizen Petition regarding COPAXONE (glatiramer acetate injection). The FDA declined to review the CP "without comment on the approvability of any Abbreviated New Drug Application or New Drug Application for a glatiramer acetate injection drug product as it would be premature and inappropriate to do so at this time." By March 26, 2009 the agency’s guidelines require a response to this Citizen Petition.

The requests that Teva presented in its Citizen Petition is not yet acted upon by the FDA According to the Agency, it is not possible to render a final decision on specific requirements for approval of any ANDA or NDA for glatiramer acetate injection "when a decision on the approvability of any such application has not been made."

A generic version of COPAXONE(R: 29.44, 2.14, 7.84%) cannot be introduced before it receives final approval of its ANDA from the Agency. COPAXONE(R: 29.44, 2.14, 7.84%) is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence. Due to the variability of the composition of the polymers, Teva believes that fully characterizing this mixture would be extremely difficult, if not impossible. Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Therefore, Teva believes that evidence supporting the effectiveness of a generic copy of glatiramer acetate cannot be derived from bioequivalence studies but rather must be derived from full-fledged clinical studies using clinical outcomes.

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