Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTH	Oct-23	Nov-23	Dec-23	Jan-24	Feb-24	Mar-24	Apr-24	May-24	Jun-24	Jul-24	Aug-24	Sep-24	FY-2024
Approvals	57	51	53	56	52	48	65	71	50	63			566
First-Time Generics	4	4	4	6	7	2	10	12	4	6			59
First-Cycle Approvals	10	6	12	9	13	7	19	7	9	12			104
Imminent Actions	6	7	9	5	5	7	8	7	3	10			67
Tentative Approvals	16	17	11	17	11	13	12	13	15	12			137
First-Cycle Tentative Approvals	4	0	0	0	2	1	2	2	0	1			12
Imminent Actions	4	5	5	2	1	4	4	3	1	0			29
Complete Responses	141	137	131	136	144	120	112	87	116	119			1243
Original ANDA Refuse to Receive	4	2	1	3	1	5	1	0	2	3			22
Standard	4	1	1	2	1	5	1	0	1	3			19
Priority	0	1	0	1	0	0	0	0	1	0			3
Original Acknowledgements	33	49	36	84	75	51	53	68	55	51			555
Withdrawals	8	27	10	14	10	5	34	8	26	30			172
Approved ANDA	0	18	0	8	0	0	24	0	11	18			79
Unapproved ANDA	8	9	10	6	10	5	10	8	15	12			93
PAS Approvals	203	108	140	120	141	127	240	130	93	133			1435
PAS Refuse to Receive	0	0	0	1	0	0	0	0	0	1			2
PAS Withdrawals	2	17	2	8	17	10	8	6	3	6			79
Information Requests	336	395	370	318	392	353	344	360	331	357			3556
Originals	135	169	175	173	192	192	171	217	169	204			1797
Supplements	201	226	195	145	200	161	173	143	162	153			1759
Discipline Review Letters	193	162	158	160	157	178	159	233	227	170			1797
DMF Completeness Assessment	84	83	32	39	46	39	40	22	21	22			428
Reclassification of a Facility-Based Major CRL Granted	6	5	6	8	9	12	18	18	11	9			102
Reclassification of a Facility-Based Major CRL Denied	0	0	0	0	1	1	0	2	1	3			8
Pending ANDAs Awaiting FDA Action +	1477	1417	1475	1451	1427	1452	1476	1486	1484	1460			--
ANDAs Awaiting Applicant Action ++	2056	2104	2100	2093	2109	2095	2054	2006	2004	1995			--
Tentative Approvals +++	482	494	494	496	494	494	497	498	506	508			--
Complete Responses ++++	1574	1610	1606	1597	1615	1601	1557	1508	1498	1487			--

 

SUBMISSIONS BY MONTH	Oct-23	Nov-23	Dec-23	Jan-24	Feb-24	Mar-24	Apr-24	May-24	Jun-24	Jul-24	Aug-24	Sep-24	FY-2024
ANDAs *	26	51	119	37	64	57	65	52	50	47			568
Complex Products	5	13	23	7	16	10	13	7	10	11			115
Amendments	211	194	213	210	198	212	208	207	154	174			1981
Major	55	52	69	67	57	69	70	63	60	67			629
Minor	50	46	59	73	65	78	82	73	60	59			645
Unsolicited	106	96	85	70	76	65	56	71	34	48			707
Requests for Reclassification of a Facility-Based Major CRL Amendment	4	6	12	15	15	28	19	15	8	9			131
Pre-Submission Facility Correspondence	11	5	5	3	7	2	4	3	2	5			47
Supplements	947	967	778	1100	1014	1022	953	1058	835	1150			9824
CBE	818	832	640	948	891	802	833	894	706	978			8342
PAS**	129	135	138	152	123	220	120	164	129	172			1482
DMF Payments	8	22	28	28	24	25	16	14	14	33			212
Controlled Correspondence ***	264	257	213	329	321	260	262	301	278	307			2792
Level 1	235	224	190	282	287	217	236	273	241	270			2455
Level 2	29	33	23	47	34	43	26	28	37	37			337
Controlled Correspondence Requests for Clarification	1	1	1	1	0	2	3	3	1	2			15
Product Development Meetings	7	4	9	5	10	2	10	5	7	12			71
Pre-Submission Meetings	0	0	0	0	0	1	0	0	2	0			3
PSG Teleconferences	0	0	0	0	0	0	1	0	0	0			1
Pre-Submission PSG Meetings	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
Mid Cycle Review Meetings	1	0	0	0	1	0	0	2	0	1			5
Enhanced Mid Cycle Review Meetings	2	0	0	0	0	0	0	0	0	2			4
Post-CRL Clarification-Only Teleconferences	3	7	11	1	5	12	4	4	11	2			60
Post-CRL Scientific Meetings	1	1	2	1	0	1	1	0	0	1			8

 

APPROVAL TIMES BY QUARTER ^	Q1 (Oct - Dec 2023)	Q2 (Jan- Mar 2024)	Q3 (Apr - Jun 2024)	Q4 (Jul - Sept 2024)
Quarterly Mean Approval Times	39.84	42.73	42.23
Quarterly Median Approval Times	26.07	25.66	25.26
Quarterly Mean Tentative Approval Times	40.69	39.37	40.48
Quarterly Median Tentative Approval Times	29.96	23.53	29.06

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 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