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  4. How Drugs are Developed and Approved
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  6. Abbreviated New Drug Application (ANDA)
  7. Activities Report of the Generic Drugs Program (FY 2021) Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Activities Report of the Generic Drugs Program (FY 2021) Monthly Performance

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 0 1 7 4 *           21
Standard - GDUFA II 2 5 0 0 7 2 *           16
Priority - GDUFA II 1 1 0 1 0 2 *           5
GDUFA I 0 0 0 0 0 0 *           0
Acknowledgement - Original 52 47 31 57 88 61 *           336
Refuse to Receive (RTR) - PAS 0 0 0 0 0 0 *           0
Withdrawals  (all original ANDAs) 7 36 9 23 36 9 *           120
Approved ANDA 2 21 0 12 24 0 *           59
Unapproved ANDA 5 15 9 11 12 9 *           61
Withdrawals  (PAS) 5 5 5 3 9 0 *           27
Approvals  78 55 63 62 72 63 55           448
First Time Generics 9 3 7 5 16 8 11           59
 Not First Time Generics 69 52 56 57 56 55 44           389
First Cycle Approvals 19 7 10 17 9 17 *           79
Not First Cycle Approvals 59 48 53 45 63 46 *           314
Tentative Approvals  15 21 22 8 7 11 17           101
First Cycle Tentative Approvals (included above) 3 4 2 1 0 2 *           12
Complete Responses (CR) 167 171 154 157 183 140 149           1121
Information Requests (IR) 359 334 370 307 416 409 *           2195
Originals 215 184 203 177 236 258 *           1273
Supplements 144 150 167 130 180 151 *           922
Discipline Review Letters (DRL) 199 166 168 131 158 204 *           1026
Drug Master File Completeness Assessment (DMF CA) 52 73 59 58 43 43 *           328
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 36 50 131 60           461
Amendments 176 204 292 179 191 235 *           1277
Major 77 88 152 91 83 103 *           594
Minor 51 81 79 45 55 71 *           382
Unsolicited Amendments ++ 48 35 61 43 53 61 *           301
Pre-Submission Facility Correspondence 12 3 3 6 3 2 *           29
CBE Supplements  958 961 787 611 562 844 *           4723
PAS Supplements +++ 126 112 122 83 101 120 *           664
DMFs - Type II 34 63 90 25 46 93 *           351
GDUFA YEAR (Receipts) 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
Controls ++++ 312 305 280 329 371 402 *           1999
Requests for Clarfication 3 2 3 1 1 7 *           17
Post CR Meeting Requests This Month 8 5 2 3 7 8 *           33

 

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.         

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