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.
| GDUFA YEAR 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 | |||||||||||||
| First-Time Generics | |||||||||||||
| First-Cycle Approvals | |||||||||||||
| Imminent Actions | |||||||||||||
| Tentative Approvals | |||||||||||||
| First-Cycle Tentative Approvals | |||||||||||||
| Imminent Actions | |||||||||||||
| Complete Responses | |||||||||||||
| Original ANDA Refuse to Receive | |||||||||||||
| Standard | |||||||||||||
| Priority | |||||||||||||
| Original Acknowledgements | |||||||||||||
| Withdrawals | |||||||||||||
| Approved ANDA | |||||||||||||
| Unapproved ANDA | |||||||||||||
| Prior Approval Supplements (PAS) | |||||||||||||
| Approvals | |||||||||||||
| Withdrawals | |||||||||||||
| Refuse to Receive | |||||||||||||
| Information Requests | |||||||||||||
| Originals | |||||||||||||
| Supplements | |||||||||||||
| Discipline Review Letters | |||||||||||||
| Standard | |||||||||||||
| Priority | |||||||||||||
| Drug Master File (DMF) Completeness Assessment | |||||||||||||
| “Off-Cycle” Solicited DMF Amendments Reviewed | |||||||||||||
| Priority | |||||||||||||
| Non-Priority | |||||||||||||
| Reclassification of a Facility-Based Major Complete Response Letter (CRL) Granted | |||||||||||||
| Reclassification of a Facility-Based Major Complete Response Letter (CRL) Denied | |||||||||||||
| Pending ANDAs Awaiting FDA Action + | -- | ||||||||||||
| ANDAs Awaiting Applicant Action ++ | -- | ||||||||||||
| Tentative Approvals +++ | -- | ||||||||||||
| Complete Responses ++++ | -- | ||||||||||||
| GDUFA YEAR SUBMISSIONS BY MONTH | |||||||||||||
| Abbreviated New Drug Applications (ANDA) * | |||||||||||||
| Complex Products | |||||||||||||
| Amendments | |||||||||||||
| Major | |||||||||||||
| Reclassification of a Facility-Based Major CRL (included in Major, above) |
|||||||||||||
| Minor | |||||||||||||
| Unsolicited | |||||||||||||
| Pre-Submission Facility Correspondence | |||||||||||||
| Supplements | |||||||||||||
| Changes Being Effected | |||||||||||||
| Prior Approval Supplements ** | |||||||||||||
| DMF Payments | |||||||||||||
| Requests for Review of DMF prior to ANDA or PAS Submission | |||||||||||||
| Controlled Correspondence *** | |||||||||||||
| Level 1 | |||||||||||||
| Level 2 | |||||||||||||
| Controlled Correspondence Requests for Clarification | |||||||||||||
| Product Development Meeting | |||||||||||||
| Pre-Submission Meeting | |||||||||||||
| PSG Teleconference | |||||||||||||
| Pre-Submission PSG Meeting | |||||||||||||
| Post-Submission PSG Meeting | |||||||||||||
| Mid Cycle Review Meeting | |||||||||||||
| Enhanced Mid Cycle Review Meeting | |||||||||||||
| Post-CRL Clarification-Only Teleconference | |||||||||||||
| Post-CRL Scientific Meeting |
| GDUFA YEAR APROVAL TIMES BY QUARTER # | Q1 (Oct - Dec 2023) | Q2 (Jan- Mar 2023) | Q3 (Apr - Jun 2023) | Q4 (Jul - Sept 2023) |
|---|---|---|---|---|
| Quarterly Mean Approval Times | ||||
| Quarterly Median Approval Times | ||||
| Quarterly Mean Tentative Approval Times | ||||
| Quarterly Median Tentative Approval Times |
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.
Unless otherwise noted, indented metrics are included in the count of the non-indented metric above it.
+ = Pending Abbreviated New Drug Applications (ANDAs) Awaiting FDA Action are applications currently being reviewed by FDA.
++ = ANDAs Awaiting FDA Action and ANDAs Awaiting Applicant Action represent a snapshot in time for the status of distinct original ANDAs. 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 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. 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.
*List previous monthly and quarterly activity reports here:
