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Mpower

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Mpower

Re: None

Friday, 01/07/2011 2:24:26 PM

Friday, January 07, 2011 2:24:26 PM

Post# of 253124

Starting 1/11/2011 the Hatch-Waxman 30-month stay on final FDA approval of NVS/MNTA’s Copaxone ANDA expires; starting on that date, the FDA can issue a final approval of the ANDA as it sees fit.

How unlikely would it be for the FDA to act on the Copaxone ANDA at this time? Is there any other major hurdle (that we know of) that would need to be cleared for the ANDA to be approved?
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