Generic Drugs Program Activities Report - FY 2025 Monthly Performance

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	58	67	63	53	54	62	64	67	52	47	40	689
First-Time Generics	6	4	8	9	6	10	7	17	9	5	8	3	92
First-Cycle Approvals	8	14	11	11	6	9	19	9	18	9	9	14	137
Imminent Actions	5	6	9	13	7	9	4	12	10	3	3	4	85
Tentative Approvals	20	17	25	27	16	22	16	31	22	19	13	22	250
First-Cycle Tentative Approvals	3	3	3	5	2	6	4	8	6	1	4	4	49
Imminent Actions	5	4	6	7	2	1	4	7	3	2	2	3	46
Complete Responses	118	87	118	123	111	102	125	115	85	127	82	88	1281
Original ANDAs Refuse-to-Receive	0	2	3	1	3	0	2	3	1	2	1	0	18
Standard	0	2	2	0	3	0	2	2	0	2	1	0	14
Priority	0	0	1	1	0	0	0	1	1	0	0	0	4
Original Acknowledgements	81	59	14	62	53	42	38	81	36	35	47	59	607
Withdrawals	17	5	10	11	23	4	12	7	12	10	5	10	126
Approved ANDAs	9	0	2	0	17	0	11	0	0	0	0	0	39
Unapproved ANDAs	8	5	8	11	6	4	1	7	12	10	5	10	87
PAS Approvals	160	86	133	138	153	122	128	115	113	115	102	124	1489
PAS Refuse-to-Receives	1	2	1	0	0	1	1	5	1	0	1	1	14
PAS Withdrawals	6	16	4	8	5	8	10	7	11	11	6	7	99
Information Requests ****	465	422	453	462	444	445	473	488	429	414	439	418	5352
Originals	265	274	302	301	297	235	264	299	246	227	224	206	3140
Supplements	200	148	151	161	147	210	209	189	183	187	215	212	2212
Discipline Review Letters	168	128	100	160	156	313	105	123	203	142	153	198	1949
DMF Completeness Assessments	37	26	34	47	46	37	45	43	32	38	25	52	462
Reclassifications of a Facility-Based Major CRL Granted	4	7	5	5	4	4	7	3	2	1	3	11	56
Reclassifications of a Facility-Based Major CRL Denied	0	1	0	1	1	0	2	1	0	1	1	1	9
Pending ANDAs Awaiting FDA Action +	1480	1440	1438	1384	1368	1371	1363	1289	1266	1238	1259	1327	--
ANDAs Awaiting Applicant Action ++	1941	1928	1929	1956	1935	1933	1948	1981	1949	1967	1924	1891	--
Tentative Approvals +++	528	526	538	544	537	537	537	557	565	571	559	566	--
Complete Responses ++++	1413	1402	1391	1412	1398	1396	1411	1424	1384	1396	1365	1325	--

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	18	80	39	34	84	52	36	36	55	38	114	600
Complex Products	2	10	18	1	6	12	11	6	6	7	7	14	100
Amendments	172	158	186	166	171	185	170	122	211	198	172	176	2087
Major	54	50	65	53	53	46	60	38	62	53	47	62	643
Minor	60	58	72	60	63	72	62	41	56	64	65	63	736
Unsolicited	58	50	49	53	55	67	48	43	93	81	60	51	708
Requests for Reclassification of a Facility-Based Major CRL Amendment	11	5	10	3	8	8	6	1	4	3	15	8	82
Pre-Submission Facility Correspondences	4	6	2	4	0	2	3	2	3	4	1	5	36
Supplements	911	812	875	895	824	954	1083	967	1105	1040	1317	932	11715
CBEs	762	665	712	735	669	776	924	800	928	846	1128	787	9732
PASs **	149	147	163	160	155	178	159	167	177	194	189	145	1983
DMF Payments	27	22	32	30	20	32	32	26	15	34	22	82	374
Controlled Correspondence ***	318	231	293	348	338	297	362	384	375	347	262	361	3916
Level 1	276	196	241	299	294	258	309	335	323	288	222	306	3347
Level 2	42	35	52	49	44	39	53	49	52	59	40	55	569
Controlled Correspondence Requests for Clarification	0	0	0	1	1	4	2	5	1	1	1	1	17
Product Development Meeting	10	12	8	9	5	6	12	9	8	9	3	8	99
Pre-Submission Meetings	1	0	2	0	1	0	1	0	1	0	0	1	7
PSG Teleconferences	1	1	0	0	1	0	0	0	0	0	0	0	3
Pre-Submission PSG Meetings	0	0	0	0	0	0	0	0	0	0	0	0	0
Post-Submission PSG Meetings	0	0	0	0	0	0	0	0	0	0	0	0	0
Mid Cycle Review Meetings	0	0	1	1	1	1	0	0	2	0	0	0	6
Enhanced Mid Cycle Review Meetings	0	1	1	1	1	0	0	0	0	2	1	0	7
Post-CRL Clarification-Only Teleconference	5	8	7	3	2	5	6	7	8	4	6	6	67
Post-CRL Scientific Meeting	2	3	2	1	0	1	1	0	2	4	1	2	19

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	39.33	37.07	35.59
Quarterly Median Approval Times	26.22	25.26	22.60	25.26
Quarterly Mean Tentative Approval Times	37.75	30.95	29.50	39.45
Quarterly Median Tentative Approval Times	25.13	24.29	18.71	35.23

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.
**** = FY 2025 Information Requests have been updated due to a new tracking process.

^ = 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 Activities Report - FY 2025 Monthly Performance

Note

Abbreviations

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