Drugs

Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance

GDUFA YEAR/Actions This Month18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Refuse to Receive (RTR) - Originals7 44 6 *      22
Standard - GDUFA II6 331 4 *      17
Priority - GDUFA II1 110 2 *      5
GDUFA I0 000 0 *      0
Acknowledgement - Original54 906669 86 *      365
Refuse to Receive (RTR) - PAS0 011 0 *      2
Withdrawals  (all original ANDAs)54 91930 13 *      125
Approved ANDA31 61010 3 *      60
Unapproved ANDA23 3920 10 *      65
Withdrawals  (PAS)9 234 11 *      29
Approvals ++++110 996982 83 89      532
   First Cycle Approvals (included above)24 111017 12 *      74
Tentative Approvals ++++22 323924 19 17      153
    First Cycle Tentative Approvals (included above)5 624 2 *      19
Complete Responses (CR)175 230144206 162 206      1123
Information Requests (IR)372 364290357 303 *      1686
Originals247 249207230 203 *      1136
Supplements125 11583127 100 *      550
Discipline Review Letters (DRL)180 254243275 247 *      1199
Drug Master File Completeness Assessment (DMF CA)55 584830 58 *      249
GDUFA YEAR (Receipts)
Submissions This Month
18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Abbreviated New Drug Applications (ANDA) +83 5410774 76 118      512
ANDA Amendments225 187199180  204 *      995
Major134 979076 90 *      487
Minor90 88101101 110 *      490
Unsolicited Amendments **1 283 4 *      18
Pre-Submission Facility Correspondence12 254 5 *      28
CBE Supplements 596 597604679 625 *      3101
PAS Supplements ++76 656769 59 *      336
DMFs - Type II74 446339 49 *      269
GDUFA YEAR (Receipts)18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Controls +++240 246249264 252 *      1251
Requests for Clarification4 328 4 *      21
Post CR Meeting Requests This month5 1786 7 *      43

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.
** = Unsolicited Amendments only include amendments submitted between review cycles.
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).
++ = PAS Supplements do not include REMS PAS supplements.
+++ = Controls count only those requests deemed appropriate for a control.
++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications, including split approvals (final approvals of certain strengths in an ANDA at the same time that certain other strengths are tentatively approved) and subsequent tentative approvals of applications that have previously been tentatively approved. 

Page Last Updated: 04/09/2019
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