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Teva’s Copaxone Suit Is “Absolutely Unprecedented,” FDA Says

 
• By Brenda Sandburg

FDA says Teva’s argument to court about dire impact of potential glatiramer ANDAs does not match its statements to investors.

Exasperated at Teva Pharmaceutical Industries Ltd.’s latest attempt to block approval of ANDAs for generic Copaxone (glatiramer), FDA told a district court that it should decline Teva’s “remarkable invitation” to determine whether an application should be approved before the agency decides to do so.

In a May 12 filing, FDA asked the court to toss Teva’s suit against the agency, which seeks...

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