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  1. Generic Drug User Fee Amendments

Generic Drugs Program Monthly and Quarterly Activities Report

With the start of GDUFA III in FY 2023, the Generic Drugs Program monthly and quarterly activities reports were combined into one report. Also, reported metrics have been updated to reflect reporting requirements outlined in the GDUFA III Commitment Letter.

ACTIONS BY MONTH Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 FY-2023
Approvals 58 60 52 56 46 96 64 63 76 69 98   738
First-Time Generics 1 3 7 4 5 4 5 6 8 18 22   83
First-Cycle Approvals 14 13 10 9 6 16 11 13 13 10 23   138
Imminent Actions 7 10 7 9 6 14 4 7 5 10 14   93
Tentative Approvals 13 13 7 20 21 21 10 18 12 15 12   162
First-Cycle Tentative Approvals 0 2 1 2 0 3 2 3 1 2 2   18
Imminent Actions 1 3 3 1 3 6 2 5 3 3 4   34
Complete Responses 148 120 124 140 141 161 92 105 120 104 118   1373
Original ANDA Refuse to Receive 1 2 5 5 3 4 3 2 4 1 2   32
Standard 1 2 4 3 2 3 1 1 4 1 1   23
Priority 0 0 1 2 1 1 2 1 0 0 1   9
Original Acknowledgements 26 97 40 83 76 50 47 93 51 45 53   661
Withdrawals 3 9 11 28 9 23 22 4 23 13 16   161
Approved ANDA 0 0 7 0 0 12 14 0 1 7 0   41
Unapproved ANDA 3 9 4 28 9 11 8 4 22 6 16   120
PAS Approvals 117 96 103 94 98 159 120 114 118 115 125   1259
PAS Refuse to Receives 0 0 2 1 1 0 0 1 0 1 0   6
PAS Withdrawals 5 7 7 5 8 8 6 9 5 2 4   66
Information Requests 297 324 297 326 325 385 325 322 342 298 346   3587
Originals 178 209 144 170 194 232 176 200 190 173 176   2042
Supplements 119 115 153 156 131 153 149 122 152 125 170   1545
Discipline Review Letters 224 201 210 179 146 297 156 195 225 193 172   2198
DMF Completeness Assessment 45 14 23 49 31 52 26 35 25 24 37   361
Reclassification of a Facility-Based Major CRL Granted 0 0 1 1 0 6 0 3 0 2 1   14
Reclassification of a Facility-Based Major CRL Denied 0 1 3 0 0 0 0 0 0 0 0   4
Pending ANDAs Awaiting FDA Action + 1584 1615 1678 1646 1609 1586 1638 1647 1593 1586 1545   --
ANDAs Awaiting Applicant Action ++ 2177 2144 2108 2111 2134 2135 2084 2064 2060 2039 2018   --
Tentative Approvals +++ 469 470 466 473 485 484 477 475 481 487 487   --
Complete Responses ++++ 1708 1674 1642 1638 1649 1651 1607 1589 1579 1552 1531   --

 

SUBMISSIONS BY MONTH Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 FY-2023
ANDAs * 34 76 109 41 38 112 44 58 55 36 57   660
Complex Products  6 8 20 5 8 15 9 9 11 8 7   106
Amendments 187 247 246 194 211 255 219 236 229 234 217   2475
Major 77 97 75 66 88 89 75 72 78 74 65   856
Minor 55 65 82 59 58 67 61 63 49 49 61   669
Unsolicited 55 85 89 69 65 99 83 101 102 111 91   950
Requests for Reclassification of a Facility-Based Major CRL Amendment 13 8 0 4 7 5 2 2 1 3 9   54
Pre-Submission Facility Correspondence 7 4 4 3 1 2 0 4 7 4 3   39
Supplements 693 727 676 688 727 921 839 1183 1012 874 916   9256
CBE 584 574 566 591 623 757 712 986 866 754 775   7788
PAS ** 109 153 110 97 104 164 127 197 146 120 141   1468
DMF Payments 14 22 33 33 28 31 17 23 15 27 43   286
Controlled Correspondence *** 267 303 277 286 296 378 278 349 313 325 284   3356
Level 1 235 280 253 255 271 336 240 314 280 294 249   3007
Level 2 32 23 24 31 25 42 38 35 33 31 35   349
Controlled Correspondence Requests for Clarification 2 2 3 1 5 0 2 1 1 2 3   22
Product Development Meetings 8 4 13 3 8 7 11 8 11 12 7   92
Pre-Submission Meetings 0 3 0 0 0 0 0 3 1 1 1   9
PSG Teleconferences 0 0 0 0 0 0 0 1 0 0 0   1
Pre-Submission PSG Meetings 0 0 0 0 0 0 0 0 0 0 0   0
Post-Submission PSG Meetings 0 0 0 0 0 0 0 0 0 0 0   0
Mid Cycle Review Meetings 0 0 0 0 0 0 0 0 0 1 0   1
Enhanced Mid Cycle Review Meetings 0 0 0 0 0 0 0 0 1 0 0   1
Post-CRL Clarification-Only Teleconferences 7 5 9 7 4 6 7 5 6 3 5   64
Post-CRL Scientific Meetings 3 0 2 2 2 1 1 0 3 0 4   18

 

APPROVAL TIMES BY QUARTER ^ Q1 (Oct - Dec 2022) Q2 (Jan- Mar 2023) Q3 (Apr - Jun 2023) Q4 (Jul - Sept 2023)
Quarterly Mean Approval Times 28.82 38.11 35.09  
Quarterly Median Approval Times 20.60 23.45 23.10  
Quarterly Mean Tentative Approval Times 25.32 39.88 30.09  
Quarterly Median Tentative Approval Times 20.31 36.76 25.36  

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.
Indented metrics are included in the count of the non-indented metric above it.

Abbreviations:
ANDA = Abbreviated New Drug Application
PAS = Prior Approval Supplements
DMF = Drug Master File
CRL = Complete Response Letter
CBE = Changes Being Effected
PSG = Product-Specific Guidances

+ = Pending ANDAs Awaiting FDA Action are applications currently being reviewed by FDA. Many of these applications have been reviewed and found “not approvable” in a previous cycle and have been resubmitted by the applicant for another cycle of review and assessment. These metrics are calculated at the end of the month or just thereafter.

++ = ANDAs Awaiting Applicant Action represent a snapshot in time for the status of distinct original ANDAs. These metrics are calculated at the end of the month or just thereafter.

+++ = ANDAs Awaiting Applicant TA are applications that have a status of ‘TA’ or Tentative Approval. If a generic drug product is ready for approval but cannot be approved due to a patent or exclusivity related to the reference listed drug product, FDA issues a tentative approval letter to the applicant, and the tentative approval letter details the basis for the tentative approval. A tentative approval does not allow the applicant to market the generic drug product in the United States. The Federal Food, Drug, and Cosmetic Act (FD&C Act) delays final approval of the generic drug product until all patent or exclusivity issues have been resolved or, in some cases, until a 30-month stay associated with patent litigation has expired.

++++ = Applications Awaiting Applicant Action are applications that have a status of ‘CR’ or Complete Response. These applications have been reviewed by FDA and the data submitted are inadequate to support approval.

* = 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.

^ = Mean/ Median AP/TA calculated as the difference between the first full approval (AP) date or the first Tentative Approval (TA) date and the date the original application was accepted for filing divided by the average number of days per month (30.4375). The unit for each of these metrics is months.

Previous Monthly Reports

Previous Quarterly Reports

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