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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 *         25
Standard - GDUFA II 1 3 3 7 1 3 3 *         21
Priority - GDUFA II 0 0 1 0 2 0 1 *         4
GDUFA I 0 0 0 0 0 0 0 *         0
Acknowledgement - Original 37 55 56 67 114 63 65 *         457
Refuse to Receive (RTR) - PAS 1 0 0 2 0 0 0 *         3
Withdrawals  (all original ANDAs) 41 20 15 32 31 51 21 *         211
Approved ANDA 1 2 6 21 18 44 13 *         105
Unapproved ANDA 40 18 9 11 13 7 8 *         106
Withdrawals  (PAS) 15 16 2 2 1 7 2 *         45
Approvals ++++ 57 59 63 49 51 60 65 63         467
First-Time Generics 1 5 15 1 6 8 4 11         51
Not First-Time Generics 56 54 48 48 45 52 61 52         416
   First Cycle Approvals 10 10 7 14 4 6 12 *         63
Not First Cycle Approvals 47 49 56 35 47 54 53 *         341
Tentative Approvals ++++ 8 14 13 14 10 17 22 15         113
    First Cycle Tentative Approvals 2 3 2 3 2 2 1 *         15
Complete Responses (CR) 197 156 197 207 162 195 169 149         1432
Information Requests (IR) 340 253 240 305 355 419 383 *         2295
Originals 230 152 170 199 230 272 241 *         1494
Supplements 110 101 70  106 125 147 142 *         801
Discipline Review Letters (DRL) 188 179 203 186 182 221 230 *         1389
Drug Master File Completeness Assessment (DMF CA) 41 55 33 29 37 46 31 *         272

 

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         604
ANDA Amendments 254 188 255 233 211 231 282 *         1654
Major 86 66 112 95 74 113 133 *         679
Minor 81 65 75 79 73 63 76 *         512
Unsolicited Amendments** 87 57 68 59 64 55 73 *         463
Pre-Submission Facility Correspondence 6 1 3 5 3 6 2 *         26
CBE Supplements  721 669 854 750 693 657 944 *         5288
PAS Supplements ++  94 95 95 80 64 82 75 *         585
DMFs - Type II 41 38 84 47 43 87 40 *         380

 

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 *         2041
Requests for Clarfication 7 2 1 9 6 2 4 *         31
Post CR Meeting Requests This Month 5 5 5 3 2 7 11 *         38

 

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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