Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTH	Oct-24	Nov-24	Dec-24	Jan-25	FY-2025
Approvals	62	58	67	63	250
First-Time Generics	6	4	8	9	27
First-Cycle Approvals	8	14	11	11	44
Imminent Actions	5	6	9	13	33
Tentative Approvals	20	17	25	27	89
First-Cycle Tentative Approvals	3	3	3	5	14
Imminent Actions	5	4	6	7	22
Complete Responses	118	87	118	123	446
Original ANDAs Refuse-to-Receive	0	2	3	1	6
Standard	0	2	2	0	4
Priority	0	0	1	1	2
Original Acknowledgements	81	59	14	62	216
Withdrawals	17	5	10	11	43
Approved ANDAs	9	0	2	0	11
Unapproved ANDAs	8	5	8	11	32
PAS Approvals	160	86	133	138	517
PASs given Refuse-to-Receive	1	2	1	0	4
PAS Withdrawals	6	16	4	8	34
Information Requests	407	344	343	356	1450
Originals	204	195	194	195	788
Supplements	203	149	149	161	662
Discipline Review Letters	168	128	100	160	556
DMF Completeness Assessments	37	26	34	47	144
Reclassifications of a Facility-Based Major CRL Granted	4	7	5	5	21
Reclassifications of a Facility-Based Major CRL Denied	0	1	0	1	2
Pending ANDAs Awaiting FDA Action +	1480	1440	1438	1384	--
ANDAs Awaiting Applicant Action ++	1941	1928	1929	1956	--
Tentative Approvals +++	528	526	538	544	--
Complete Responses ++++	1413	1402	1391	1412	--

SUBMISSIONS BY MONTH	Oct-24	Nov-24	Dec-24	Jan-25	FY-2025
ANDAs *	14	18	80	39	151
Complex Products	2	10	18	1	31
Amendments	172	158	186	166	682
Major	54	50	65	53	222
Minor	60	58	72	60	250
Unsolicited	58	50	49	53	210
Requests for Reclassification of a Facility-Based Major CRL Amendment	11	5	10	3	29
Pre-Submission Facility Correspondences	4	6	2	4	16
Supplements	911	812	875	895	3493
CBEs	762	665	712	735	2874
PASs **	149	147	163	160	619
DMF Payments	27	22	32	30	111
Controlled Correspondence ***	318	231	293	348	1190
Level 1	276	196	241	299	1012
Level 2	42	35	52	49	178
Controlled Correspondence Requests for Clarification	0	0	0	1	1
Product Development Meeting	10	12	8	9	39
Pre-Submission Meetings	1	0	2	0	3
PSG Teleconferences	1	1	0	0	2
Pre-Submission PSG Meetings	0	0	0	0	0
Post-Submission PSG Meetings	0	0	0	0	0
Mid Cycle Review Meetings	0	0	1	1	2
Enhanced Mid Cycle Review Meetings	0	1	1	1	3
Post-CRL Clarification-Only Teleconference	5	8	7	3	23
Post-CRL Scientific Meeting	2	3	2	1	8

APPROVAL TIMES BY QUARTER ^	Q1 (Oct - Dec 2024)	Q2 (Jan- Mar 2025)	Q3 (Apr - Jun 2025)	Q4 (Jul - Sept 2025)
Quarterly Mean Approval Times	42.40
Quarterly Median Approval Times	26.22
Quarterly Mean Tentative Approval Times	37.75
Quarterly Median Tentative Approval Times	25.13

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.

Generic Drugs Program Monthly and Quarterly Activities Report

Note

Abbreviations

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