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Re: ziploc_1 post# 5085

Thursday, 04/25/2013 3:53:32 PM

Thursday, April 25, 2013 3:53:32 PM

Post# of 425923
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In addition to what you said, there's the new PDUFA program. Effective 11-1-2012, pg 6 implies at the acceptance of an application the FDA will have decided it's exclusivity status.

Thus, the FDA has decided. Indication Anchor or Marine doesn't change the molecular formula or touch on any new MAPP documents. We either hear this month or the FDA disregards it's own rules.

http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf
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