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.
Previous Activities Reports
- Activities Report of the Generic Drug Program (FY 2020)
- Activities Report of the Generic Drug Program (FY 2019)
- Activities Report of the Generic Drug Program (FY 2018)
- Activities Report of the Generic Drug Program (FY 2017)
- Activities Report of the Generic Drug Program (FY 2016)
- Activities Report of the Generic Drug Program (FY 2015)
- Activities Report of the Generic Drug Program (FY 2014)
- Activities Report of the Generic Drug Program (FY 2013)