Elite Pharmaceuticals Inc (ELTP)

[justdosomething]

Hey Sharpei, is this something to look at or
am I off on what it is. Was found on this site. Is Elite in a First cycle filing review right now or is this something else? Thanks

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/UCM243358.pdf


First Cycle Filing Review Notification
Commitment: Report substantive review issues (or lack thereof)
within 14 Days after the 60-Day filing date for
original NDAs/BLAs and efficacy supplements
The table below summarizes the annual review-time commitments for first cycle filing
review notifications for original NDAs and BLAs and efficacy supplements. FDA is to
report substantive review issues (or lack thereof) identified during the initial filing review to
the applicant by letter, telephone conference, facsimile, secure e-mail, or other expedient
means within 14 days after the 60-day filing date.
First Cycle Filing Review
Notification Type
Review-Time
Commitment
Performance Level
FY 2008 – FY 2012
Original NDAs/BLAs
Efficacy Supplements
Within 14 days after
60-day filing date 90% on time
Workload
The PDUFA total for first cycle filing review
notifications filed in FY 2010 was the lowest
number filed in 5 years and consistent with
declines in the numbers of NDAs, BLAs, and
efficacy supplements filed (see earlier
sections as well as corresponding graph and
table).
Type
First Cycle Filing Review Notifications
FY 06 FY 07 FY 08 FY 09* FY 10
NDAs 111 104 119 125 98
BLAs 12 15 18 20 7
PDUFA Total 123 119 137 145 105
Efficacy Supplements† 142 148 122 116 101
* The number of original applications filed in any given year may not match the number of first cycle notifications due to
the status of an application at the time the data are closed for reporting. Numbers are updated as appropriate in later FY
reports. FY 2009 numbers were changed to reflect updates to data presented in the FY 2009 PDUFA Performance
Report.
† The first cycle filing review notification commitment applies to original NDAs and BLAs and efficacy supplements only.
First cycle filing review commitments do not apply to NDA labeling supplements, even though these are counted as
efficacy supplements for other PDUFA performance purposes. Therefore, the number of filing review notifications for
efficacy supplements is generally less than the total number of efficacy supplements filed.
First Cycle Filing Review