Thursday, April 16, 2015 5:22:52 PM
The short answer: Mylan has submitted Natco's generic copaxone for FDA approval. The FDA has tested Natco/ Mylan's product and says, it is not the same as the reference Teva product. MNTA's is. MNTA will remain the sole generic.
Yes and no in that MYL has surely altered that NATCO ex-US product. Have they or anyone else done so to the same precise degree as MNTA is the big question (For the time being and I'd say at least 6 months the clear answer is "no").
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