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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                   170
First-Time Generics 1 3 6                   10
First-Cycle Approvals 14 13 10                   37
Imminent Actions 7 10 7                   24
Tentative Approvals 13 13 7                   33
First-Cycle Tentative Approvals 0 2 1                   3
Imminent Actions 1 3 3                   7
Complete Responses 148 120 124                   392
Original ANDA Refuse to Receive 1 2 5                   8
Standard 1 2 4                   7
Priority 0 0 1                   1
Original Acknowledgements 26 97 40                   163
Withdrawals 3 9 11                   23
Approved ANDA 0 0 7                   7
Unapproved ANDA 3 9 4                   16
PAS Approvals 117 96 103                   316
PAS Refuse to Receives 0 0 2                   2
PAS Withdrawals 5 7 7                   19
Information Requests 297 324 297                   918
Originals 178 209 144                   531
Supplements 119 115 153                   387
Discipline Review Letters 224 201 210                   635
DMF Completeness Assessment 45 14 23                   82
Reclassification of a Facility-Based Major CRL Granted 0 0 1                   1
Reclassification of a Facility-Based Major CRL Denied 0 1 3                   4
Pending ANDAs Awaiting FDA Action + 1584 1615 1678                   --
ANDAs Awaiting Applicant Action ++ 2177 2144 2108                   --
Tentative Approvals +++ 469 470 466                   --
Complete Responses ++++ 1708 1674 1642                   --

 

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                   219
Complex Products  6 8 20                   34
Amendments 187 247 246                   680
Major 77 97 75                   249
Minor 55 65 82                   202
Unsolicited 55 85 89                   229
Requests for Reclassification of a Facility-Based Major CRL Amendment 13 8 0                   21
Pre-Submission Facility Correspondence 7 4 4                   15
Supplements 693 727 676                   2096
CBE 584 574 566                   1724
PAS ** 109 153 110                   372
DMF Payments 14 22 33                   69
Controlled Correspondence *** 267 303 277                   847
Level 1 235 280 253                   768
Level 2 32 23 24                   79
Controlled Correspondence Requests for Clarification 2 2 3                   7
Product Development Meetings 8 4 13                   25
Pre-Submission Meetings 0 3 0                   3
PSG Teleconferences 0 0 0                   0
Pre-Submission PSG Meetings 0 0 0                   0
Post-Submission PSG Meetings 0 0 0                   0
Mid Cycle Review Meetings 0 0 0                   0
Enhanced Mid Cycle Review Meetings 0 0 0                   0
Post-CRL Clarification-Only Teleconferences 7 5 9                   21
Post-CRL Scientific Meetings 3 0 2                   5

 

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      
Quarterly Median Approval Times 20.6      
Quarterly Mean Tentative Approval Times 25.32      
Quarterly Median Tentative Approval Times 20.31      

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 = Abbreivated 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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