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Teva gets (non)response from FDA on Copaxone

Executive Summary

Teva's petition requesting that ANDAs for its multiple sclerosis treatment Copaxone (glatiramer) should contain clinical data has been nominally rejected by FDA. 1FDA's denial is made "without comment on the approvability" of any application "because it would be premature and inappropriate to do so at this time." The response appears to be part of the agency's new strategy of answering petitions within the 180-day congressional deadline but not reaching a definitive conclusion on the questions because applications may still be undergoing review. The denials have frustrated firms, which are left with the choice of suing the agency or repetitioning, but FDA thinks the approach is "pretty clever" (2"The Pink Sheet," March 2, 2009, p. 29)
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