But isn't the low-volume Copaxone considered a new drug?
Yes.
So the approval process is much more difficult.
More difficult than what? Surely, the FDA review of Teva’s low-volume Copaxone, which differs from branded Copaxone only in the concentration of active ingredient per ml, will be very much simpler than the FDA review of NVS/MNTA’s Copaxone ANDA.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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