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

Generic Drugs Program Activities Report - Monthly Performance

GDUFA YEAR/
Actions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Refuse to Receive (RTR) - Originals 3 3 3 3 9 3 5 5 6 2 4 3 49
Standard - GDUFA II 3 2 1 1 8 3 3 5 5 2 2 3 38
Priority - GDUFA II 0 1 2 2 1 0 2 0 1 0 2 0 11
GDUFA I 0 0 0 0 0 0 0 0 0 0 0 0 0
Acknowledgement - Original 61 63 45 83 91 62 70 94 77 48 56 69 819
Refuse to Receive (RTR) - PAS 0 1 0 0 0 0 1 0 0 0 0 0 2
Withdrawals (all original ANDAs) 201 5 31 17 10 25 30 25 20 6 61 6 437
Approved ANDA 193 0 18 12 2 15 4 16 16 0 38 2 316
Unapproved ANDA 8 5 13 5 8 10 26 9 4 6 23 4 121
Withdrawals (PAS) 8 7 24 5 18 8 10 7 5 4 2 8 106
Approvals 49 67 34 61 59 63 45 84 52 65 75 68 722
First Time Generics 6 8 5 7 7 14 11 30 6 6 6 9 115
Not First Time Generics 43 59 29 54 52 49 34 54 46 59 69 59 607
First Cycle Approvals 12 13 4 17 8 10 8 11 13 17 9 8 130
Not First Cycle Approvals 37 54 30 44 51 53 37 73 39 48 66 60 592
Tentative Approvals 14 8 22 19 12 18 17 10 19 13 22 9 183
First Cycle Tentative Approvals (included above) 2 0 2 1 2 0 3 0 1 3 0 0 14
Complete Responses (CR) 152 168 108 195 141 141 168 125 159 171 142 141 1811
Information Requests (IR) 365 353 308 377 422 466 324 409 391 291 349 315 4370
Originals 210 233 194 236 260 284 193 264 228 172 235 188 2697
Supplements 155 120 114 141 162 182 131 145 163 119 114 127 1673
Discipline Review Letters (DRL) 188 201 202 165 168 243 141 184 314 168 231 279 2484
Drug Master File Completeness Assessment (DMF CA) 57 73 38 42 44 58 36 32 45 42 46 32 545

 

GDUFA YEAR (Receipts)
Submissions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Abbreviated New Drug Applications (ANDA) + 24 51 135 61 50 125 64 74 58 60 57 98 857
Amendments 220 188 236 200 225 261 205 218 213 152 180 215 2513
Major 95 77 101 68 76 95 84 95 91 67 83 76 1008
Minor 57 45 78 65 77 83 63 72 67 49 60 90 806
Unsolicited Amendments ++ 68 66 57 67 72 83 58 51 55 36 37 49 699
Pre-Submission Facility Correspondence 14 2 2 11 2 6 4 2 10 6 0 3 62
CBE Supplements 811 753 821 643 548 748 669 665 691 668 788 621 8426
PAS Supplements +++ 120 105 114 95 85 138 108 95 131 98 110 97 1296
DMFs - Type II 49 50 77 55 58 82 48 52 65 72 54 60 722
Controls ++++ 323 339 255 322 347 356 350 311 315 225 297 292 3732
Requests for Clarfication 1 2 3 4 2 1 3 0 0 0 1 3 20
Post CR Meeting Requests This Month 5 3 5 3 4 4 7 4 7 5 7 5 59

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.
+ = 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. FY 2022 controls were updated at FY 2022 closeout to accurately reflect monthly requests after migration to a new tracking system.

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