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Surprise! Mylan's Copaxone Generic Sets Teva Up For A Struggle

 
• By Jessica Merrill

FDA cleared Mylan's generic version of Copaxone 40mg even after management warned investors not to expect action until 2018. Mylan said it will launch "imminently, but Teva said a launch ahead of the pending appeals case would be "at risk."

FDA approved background, 3D rendering, blue street sign

Mylan NV has won FDA approval of the first generic version of a 40mg dose of Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer) for multiple sclerosis, setting Mylan up for a potentially lucrative commercial opportunity while adding to Teva's mounting challenges.

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Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.