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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 2020

 

GDUFA YEAR/
Actions This Month
19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020
Refuse to Receive (RTR) - Originals 1 3 4 7 3 3 4 4 1 4 *   34
Standard - GDUFA II 1 3 3 7 1 3 3 1 1 4 *   27
Priority - GDUFA II 0 0 1 0 2 0 1 3 0 0 *   7
GDUFA I 0 0 0 0 0 0 0 0 0 0 *   0
Acknowledgement - Original 37 55 56 67 114 63 65 77 73 56 *   663
Refuse to Receive (RTR) - PAS 1 0 0 2 0 0 0 0 0 2 *   5
Withdrawals  (all original ANDAs) 41 20 15 32 31 51 21 17 14 22 *   264
Approved ANDA 1 2 6 21 18 44 13 2 8 13 *   128
Unapproved ANDA 40 18 9 11 13 7 8 15 6 9 *   136
Withdrawals  (PAS) 15 16 2 2 1 7 2 6 3 6 *   60
Approvals ++++ 57 59 63 49 51 60 65 63 73 69 58   667
First-Time Generics 1 5 15 1 6 8 4 11 5 3 4   63
Not First-Time Generics 56 54 48 48 45 52 61 52 68 66 54   604
   First Cycle Approvals 10 10 7 14 4 6 12 14 13 15 *   105
Not First Cycle Approvals 47 49 56 35 47 54 53 49 60 54 *   504
Tentative Approvals ++++ 8 14 13 14 10 17 22 15 14 13 17   157
    First Cycle Tentative Approvals 2 3 2 3 2 2 1 0 1 0 *   16
Complete Responses (CR) 197 156 197 207 162 195 169 149 124 160 143   1859
Information Requests (IR) 340 253 240 305 355 419 383 414 413 387 *   3509
Originals 230 152 170 199 230 272 241 265 256 256 *   2271
Supplements 110 101 70  106 125 147 142 149 157 131 *   1238
Discipline Review Letters (DRL) 188 179 203 186 182 221 230 197 335 210 *   2131
Drug Master File Completeness Assessment (DMF CA) 41 55 33 29 37 46 31 21 35 33 *   361

 

GDUFA YEAR (Receipts)Submissions This Month 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020
Abbreviated New Drug Applications (ANDA) + 59 57 149 59 45 98 69 68 59 68 45   776
ANDA Amendments 254 188 255 233 211 231 282 226 282 218 *   2380
Major 86 66 112 95 74 113 133 102 122 90 *   993
Minor 81 65 75 79 73 63 76 61 90 56 *   719
Unsolicited Amendments** 87 57 68 59 64 55 73 63 70 72 *   668
Pre-Submission Facility Correspondence 6 1 3 5 3 6 2 5 2 2 *   35
CBE Supplements  721 669 854 750 693 657 944 833 951 858 *   7930
PAS Supplements ++  94 95 95 80 64 82 75 110 113 119 *   927
DMFs - Type II 41 38 84 47 43 87 40 28 48 50 *   506

 

GDUFA YEAR (Receipts) 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020
Controls +++ 292 246 244 330 303 341 285 270 312 355 *   2978
Requests for Clarfication 7 2 1 9 6 2 4 3 2 7 *   43
Post CR Meeting Requests This Month 5 5 5 3 2 7 11 3 4 2 *   47

 

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.
** = 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.
+ = 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.         

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