Antares Pharma, Inc. (ATRS)

[Jon20ABX]

Info (clarification) from the FDA on Otrexup approval timeline

Tappy, Jab, others...what's stated below is a copy/paste to a recent email exchange I had with the FDA. I mentioned this last week to Jab/Tappy/others on the "other" message board though that response was via a phone call conversation I had with the FDA.

TD's email question: For non-NME NDA submissions, to my undertanding, the time clock starts the day the NDA is received. Is this correct? Even though an application review is still part of the process, the time clock starts the day the application is originally received (day-stamped), not the day the application gets approved (i.e. the post-60 day filing date as with NME NDA submissions). In other words, for non-NME NDA submissions, it's 60 days + 8 months for complete non-NME review.

FDA response: This is correct. The "Program" refers to all New Molecular Entity New Drug Applications (NME NDAs) and original Biologics License Applications (BLAs), including applications that are resubmitted following a Refuse-to-File action, received from October 1, 2012, through September 30, 2017 (PDUFA V time period). Thus, for non-NME NDA submissions, the 60-day clock starts from the receipt date (that would be the earliest receipt date which is usually the Central Document Room receipt date).

PDUFA V applies to fiscal years 2013-2017. FY 2013 is from October 1 2012 through September 30 2013.