Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTH	Oct-24	Nov-24	Dec-24	Jan-25	Feb-25	Mar-25	Apr-25	May-25	Jun-25	Jul-25	Aug-25	Sep-25	FY-2025
Approvals	62												62
First-Time Generics	6												6
First-Cycle Approvals	8												8
Imminent Actions	5												5
Tentative Approvals	20												20
First-Cycle Tentative Approvals	3												3
Imminent Actions	5												5
Complete Responses	118												118
Original ANDAs Refuse-to-Receive	0												0
Standard	0												0
Priority	0												0
Original Acknowledgements	81												81
Withdrawals	17												17
Approved ANDAs	9												9
Unapproved ANDAs	8												8
PAS Approvals	160												160
PASs given Refuse-to-Receive	1												1
PAS Withdrawals	6												6
Information Requests	407												407
Originals	204												204
Supplements	203												203
Discipline Review Letters	168												168
DMF Completeness Assessments	37												37
Reclassifications of a Facility-Based Major CRL Granted	4												4
Reclassifications of a Facility-Based Major CRL Denied	0												0
Pending ANDAs Awaiting FDA Action +	1480												--
ANDAs Awaiting Applicant Action ++	1941												--
Tentative Approvals +++	528												--
Complete Responses ++++	1413												--

 

SUBMISSIONS BY MONTH	Oct-24	Nov-24	Dec-24	Jan-25	Feb-25	Mar-25	Apr-25	May-25	Jun-25	Jul-25	Aug-25	Sep-25	FY-2025
ANDAs *	14												14
Complex Products	2												2
Amendments	172												172
Major	54												54
Minor	60												60
Unsolicited	58												58
Requests for Reclassification of a Facility-Based Major CRL Amendment	11												11
Pre-Submission Facility Correspondences	4												4
Supplements	911												911
CBEs	762												762
PASs **	149												149
DMF Payments	27												27
Controlled Correspondence ***	318												318
Level 1	276												276
Level 2	42												42
Controlled Correspondence Requests for Clarification	0												0
Product Development Meeting	10												10
Pre-Submission Meetings	1												1
PSG Teleconferences	1												1
Pre-Submission PSG Meetings	0												0
Post-Submission PSG Meetings	0												0
Mid Cycle Review Meetings	0												0
Enhanced Mid Cycle Review Meetings	0												0
Post-CRL Clarification-Only Teleconference	5												5
Post-CRL Scientific Meeting	2												2

 

APPROVAL TIMES BY QUARTER ^	Q1 (Oct - Dec 2024)	Q2 (Jan- Mar 2025)	Q3 (Apr - Jun 2025)	Q4 (Jul - Sept 2025)
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. Indented metrics are included in the count of the non-indented metric above it.

Abbreviations

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.
++ = 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.

Previous Monthly Reports

• Activities Report of the Generic Drug Program (FY 2024)
• Activities Report of the Generic Drug Program (FY 2023)
• Activities Report of the Generic Drug Program (FY 2022)
• Activities Report of the Generic Drug Program (FY 2021)
• 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)

Previous Quarterly Reports

• FY 2022 | GDUFA II Quarterly Performance
• FY 2021 | GDUFA II Quarterly Performance
• FY 2020 | GDUFA II Quarterly Performance
• FY 2019 | GDUFA II Quarterly Performance
• FY 2018 | GDUFA II Quarterly Performance