Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTH	Oct-24	Nov-24	FY-2025
Approvals	62	58	120
First-Time Generics	6	4	10
First-Cycle Approvals	8	14	22
Imminent Actions	5	6	11
Tentative Approvals	20	17	37
First-Cycle Tentative Approvals	3	3	6
Imminent Actions	5	4	9
Complete Responses	118	87	205
Original ANDAs Refuse-to-Receive	0	2	2
Standard	0	2	2
Priority	0	0	0
Original Acknowledgements	81	59	140
Withdrawals	17	5	22
Approved ANDAs	9	0	9
Unapproved ANDAs	8	5	13
PAS Approvals	160	86	246
PASs given Refuse-to-Receive	1	2	3
PAS Withdrawals	6	16	22
Information Requests	407	344	751
Originals	204	195	399
Supplements	203	149	352
Discipline Review Letters	168	128	296
DMF Completeness Assessments	37	26	63
Reclassifications of a Facility-Based Major CRL Granted	4	7	11
Reclassifications of a Facility-Based Major CRL Denied	0	1	1
Pending ANDAs Awaiting FDA Action +	1480	1,440	--
ANDAs Awaiting Applicant Action ++	1941	1,928	--
Tentative Approvals +++	528	526	--
Complete Responses ++++	1413	1,402	--

SUBMISSIONS BY MONTH	Oct-24	Nov-24	FY-2025
ANDAs *	14	18	32
Complex Products	2	10	12
Amendments	172	158	330
Major	54	50	104
Minor	60	58	118
Unsolicited	58	50	108
Requests for Reclassification of a Facility-Based Major CRL Amendment	11	5	16
Pre-Submission Facility Correspondences	4	6	10
Supplements	911	812	1,723
CBEs	762	665	1,427
PASs **	149	147	296
DMF Payments	27	22	49
Controlled Correspondence ***	318	231	549
Level 1	276	196	472
Level 2	42	35	77
Controlled Correspondence Requests for Clarification	0	0	0
Product Development Meeting	10	12	22
Pre-Submission Meetings	1	0	1
PSG Teleconferences	1	1	2
Pre-Submission PSG Meetings	0	0	0
Post-Submission PSG Meetings	0	0	0
Mid Cycle Review Meetings	0	0	0
Enhanced Mid Cycle Review Meetings	0	1	1
Post-CRL Clarification-Only Teleconference	5	8	13
Post-CRL Scientific Meeting	2	3	5

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.

U.S. Food and Drug Administration

Generic Drugs Program Monthly and Quarterly Activities Report

Note

Abbreviations

Previous Monthly Reports

Previous Quarterly Reports