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  7. Generic Drugs Program Activities Report - Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Generic Drugs Program Activities Report - Monthly Performance

Fiscal Year 2021

GDUFA YEAR/
Actions This Month
20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Refuse to Receive (RTR) - Originals 3 6 *                   9
Standard - GDUFA II 2 5 *                   7
Priority - GDUFA II 1 1 *                   2
GDUFA I 0 0 *                   0
Acknowledgement - Original 52 47 *                   99
Refuse to Receive (RTR) - PAS 0 0 *                   0
Withdrawals  (all original ANDAs) 7 36 *                   43
Approved ANDA 2 21 *                   23
Unapproved ANDA 5 15 *                   20
Withdrawals  (PAS) 5 5 *                   10
Approvals 78 55 63                   196
First-Time Generics 9 3 7                   19
Not First-Time Generics 69 52 56                   177
   First Cycle Approvals 19 7 *                   26
Not First Cycle Approvals 59 48 *                   107
Tentative Approvals 15 21 22                   58
    First Cycle Tentative Approvals 3 4 *                   7
Complete Responses (CR) 167 171 154                   492
Information Requests (IR) 359 334 *                   693
Originals 215 184 *                   399
Supplements 144 150 *                   294
Discipline Review Letters (DRL) 199 166 *                   365
Drug Master File Completeness Assessment (DMF CA) 52 73 *                   125
GDUFA YEAR (Receipts) Submissions
This Month
20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Abbreviated New Drug Applications (ANDA) + 20 40 124                   184
ANDA Amendments 176 204 *                   380
Major 77 88 *                   165
Minor 51 81 *                   132
       Unsolicited Amendments++ 48 35 *                   83
Pre-Submission Facility Correspondence 12 3 *                   15
CBE Supplements  958 961 *                   1919
PAS Supplements ++ + 126 112 *                   238
DMFs - Type II 34 63 *                   97
GDUFA YEAR (Receipts) 20-Oct 20-Nov 20-Dec 20-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Controls ++++ 312 305 *                   617
Requests for Clarfication 3 2 *                   5
Post CR Meeting Requests This Month 8 5 *                   13

 

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.
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).
++= Due to system capabilities, counts for unsolicited amendments were previously based on amendments submitted after a tentative approval was issued. Starting in Oct. 2019 (FY 2020) the monthly metric report now captures all unsolicited amendments submitted to the agency.
+++ = PAS Supplements do not include REMS PAS supplements.
++++ = Controls count only those requests deemed appropriate for a control.         

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