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Posted On: 09/28/2020 4:52:59 PM
Post# of 149265
I had researched this as well and think you are correct blafarm. It unfortunately does start over. Here is the time line for Zogenix's FINTEPLA as an example of a drug that got an RTF, refiled, got a PDUFA date/priority review and then was approved
~60 Days for Review
~7 Months with Priority Review
4/8/19 - Zogenix receives refusal to file letter from FDA for FINTEPLA
9/26/19 - Zogenix resubmits NDA for FINTEPLA
11/25/19 - FDA accepts filing and gives priority review for FINTEPLA
6/26/20 - FDA approves FINTEPLA
~60 Days for Review
~7 Months with Priority Review
4/8/19 - Zogenix receives refusal to file letter from FDA for FINTEPLA
9/26/19 - Zogenix resubmits NDA for FINTEPLA
11/25/19 - FDA accepts filing and gives priority review for FINTEPLA
6/26/20 - FDA approves FINTEPLA
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