Sidney et al: Teva’s low-volume Copaxone is a new drug. Thus, Teva does not need to fully characterize low-volume Copaxone to obtain FDA approval; rather, Teva needs to show that low-volume Copaxone is safe and effective, as is the case for any new drug.
The FDA rejected Teva’s NDA for low-volume Copaxone because the dataset supporting the application is a joke. It’s preposterous to think that the FDA would accept an applicant’s claim of less severe injection-site reactions based on an open-label trial, but that’s what Teva was claiming in its rejected NDA. Regards, Dew
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