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Teva claims Copaxone is too complex to copy in latest ANDA-blocking petition to US FDA

This article was originally published in Scrip

Executive Summary

Teva Pharmaceutical Industries has asked the US FDA to intervene again in blocking the progress of generics challenges to its multiple sclerosis drug Copaxone (glatiramer acetate). This time, Teva has claimed, in effect, that Copaxone is too complex for any competitor to prove that its drug has the same active ingredient. In a new tactic, Teva is also asking the agency to convene a multidisciplinary FDA advisory panel to consider the approval of any follow-on glatiramer acetate product.



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