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Amarin Corporation plc Message Board

  • no_mo_butterfingers no_mo_butterfingers Mar 2, 2013 3:04 PM Flag

    How did AMRN file their sNDA

    Williams spoke of a 502 (b)(2) filing that could speed up the approval to 3 months, but during the CC they clearly expect PDUFA date late in the year.

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    • I assume it was a 505 (B) (1) and a request for a new indication and NCE.
      A clinical submission filed under FDA Section 505(b)(1) is an NDA is required to demonstrate clinically meaningful treatment benefits and statistically significant safety and efficacy objectives and endpoints. In addition, clinical submissions filed under FDA Section 505(b)(1) are a new chemical entities with a new indications. The new investigational drug will be administered to the patient in a new formulation, with a new dosage form, new dose strength and is patented. The pharmaceutical company and/or manufacturer seeks market exclusivity for the NDA. Approval of the NDA under Section 505(b)(1), is granted by FDA only after an extensive Phase 1, 2, 3 clinical development program. When all 3 clinical phases are complete, the pharmaceutical company and/or manufacturer, submits an NDA including all results from all studies, nonclinical, preclinical, CMC, clinical, bioanalytical, pharmacologic and pharmacokinetic to FDA. The NDA is filed, reviewed for filing completeness and then sent to the appropriate division at FDA for review. The regulatory "clock" begins for the file.

      sNDA can be filed for AMR 102 through AMR 1000's through a 505. (B) (2) and request 3 yr NME exclusivity.

      Williams

 
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