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DewDiligence

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DewDiligence

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Re: acgood post# 86100

Tuesday, 11/10/2009 7:24:49 PM

Tuesday, November 10, 2009 7:24:49 PM

Post# of 257259

When Teva wants to offer a new delivery option for Copaxone (ie, the autoject2 is now available to use with the prefilled syringes), what sort of regulatory filing process is required? I.e., if Copaxone was another Teva-Antares partner product, what regulatory path would it take?

The answer to both questions is a supplemental NDA.


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