Drugs

Activities Report of the Generic Drug Program (FY 2016)

GDUFA YEAR/Actions This Month15-Oct15-Nov15-Dec16-Jan16-Feb16-Mar16-Apr16-May16-Jun16-Jul16-Aug16-SepFY-2016
Refuse to Receive (RTR) +12 19 11 29 33 18 3140 1314 * 220
Withdrawals (all original ANDAs)18 19 14 48 27 20 20 8 34 13 * 221
Approvals +50 61 79 43 51 60 53 54 51 46 51 599
Tentative Approvals +22 6 20 17 12 16 16 20 15 10 14 168
Complete Responses (CR) +105 92 113 103 129 147 190 151 166 169 166 1531
Drug Master File Completeness Assessment (DMF CA)111 57 132 61 96 65 84 60 51 83 * 800
GDUFA YEAR (Receipts)Submissions This Month15-Oct15-Nov15-Dec16-Jan16-Feb16-Mar16-Apr16-May16-Jun16-Jul16-Aug16-SepFY-2016
Abbreviated New Drug Applications (ANDA) ++35 42 180 40 61 114 56 58 78 69 59 792
CBE Supplements623 374 386 348 410 506 540 426 499 357 * 4469
PAS Supplements34 33 47 32 45 35 33 43 39 33 * 374
GDUFA YEAR (Receipts)Submissions This Month15-Oct15-Nov15-Dec16-Jan16-Feb16-Mar16-Apr16-May16-Jun16-Jul16-Aug16-SepFY-2016
Controls +++158 101 118 126 157 204 134 186 219 168 * 1571
GDUFA Post CR Meeting Requests ++++141 143 146 148 153 156 161 163 166 169 *  
Post CR Meeting Requests this month1 2 3 2 5 3 5 2 3 3 * 29

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.

* = This data requires additional verification and will be posted when available.
+ = Revised to reflect more accurate counting by our tracking systems. For example, RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.
++ = Starting FY15, ANDA Original Receipts are reported as raw receipts (versus filed receipts).
+++ = Controls have been revised to count only those requests deemed appropriate for a control.
++++ = Cumulative and NOT specific to the month.

Page Last Updated: 09/14/2016
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