Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTH	Oct-23	Nov-23	Dec-23	Jan-24	Feb-24	Mar-24	FY-2024
Approvals	57	51	53	56	52	48	317
First-Time Generics	4	4	4	6	7	2	27
First-Cycle Approvals	10	6	12	9	13	7	57
Imminent Actions	6	7	9	5	5	7	39
Tentative Approvals	16	17	11	17	11	13	85
First-Cycle Tentative Approvals	4	0	0	0	2	1	7
Imminent Actions	4	5	5	2	1	4	21
Complete Responses	141	137	131	136	144	120	809
Original ANDA Refuse to Receive	4	2	1	3	1	5	16
Standard	4	1	1	2	1	5	14
Priority	0	1	0	1	0	0	2
Original Acknowledgements	33	49	36	84	75	51	328
Withdrawals	8	27	10	14	10	5	74
Approved ANDA	0	18	0	8	0	0	26
Unapproved ANDA	8	9	10	6	10	5	48
PAS Approvals	203	108	140	120	141	127	839
PAS Refuse to Receives	0	0	0	1	0	0	1
PAS Withdrawals	2	17	2	8	17	10	56
Information Requests	336	395	370	318	392	353	2164
Originals	135	169	175	173	192	192	1036
Supplements	201	226	195	145	200	161	1128
Discipline Review Letters	193	162	158	160	157	178	1008
DMF Completeness Assessment	84	83	32	39	46	39	323
Reclassification of a Facility-Based Major CRL Granted	6	5	6	8	9	12	46
Reclassification of a Facility-Based Major CRL Denied	0	0	0	0	1	1	2
Pending ANDAs Awaiting FDA Action +	1477	1417	1475	1451	1427	1452	--
ANDAs Awaiting Applicant Action ++	2056	2104	2100	2093	2109	2095	--
Tentative Approvals +++	482	494	494	496	494	494	--
Complete Responses ++++	1574	1610	1606	1597	1615	1601	--

SUBMISSIONS BY MONTH	Oct-23	Nov-23	Dec-23	Jan-24	Feb-24	Mar-24	FY-2024
ANDAs *	26	51	119	37	64	57	354
Complex Products	5	13	23	7	16	10	74
Amendments	211	194	213	210	198	212	1238
Major	55	52	69	67	57	69	369
Minor	50	46	59	73	65	78	371
Unsolicited	106	96	85	70	76	65	498
Requests for Reclassification of a Facility-Based Major CRL Amendment	4	6	12	15	15	28	80
Pre-Submission Facility Correspondence	11	5	5	3	7	2	33
Supplements	947	967	778	1100	1014	1022	5828
CBE	818	832	640	948	891	802	4931
PAS**	129	135	138	152	123	220	897
DMF Payments	8	22	28	28	24	25	135
Controlled Correspondence ***	264	257	213	329	321	260	1644
Level 1	235	224	190	282	287	217	1435
Level 2	29	33	23	47	34	43	209
Controlled Correspondence Requests for Clarification	1	1	1	1	0	2	6
Product Development Meeting	7	4	9	5	10	2	37
Pre-Submission Meeting	0	0	0	0	0	1	1
PSG Teleconference	0	0	0	0	0	0	0
Pre-Submission PSG Meetings	0	0	0	0	0	0	0
Post-Submission PSG Meeting	0	0	0	0	0	0	0
Mid Cycle Review Meeting	1	0	0	0	1	0	2
Enhanced Mid Cycle Review Meeting	2	0	0	0	0	0	2
Post-CRL Clarification-Only Teleconference	3	7	11	1	5	12	39
Post-CRL Scientific Meeting	1	1	2	1	0	1	6

APPROVAL TIMES BY QUARTER *	Q1 (Oct - Dec 2023)	Q2 (Jan- Mar 2024)
Quarterly Mean Approval Times	39.84	42.73
Quarterly Median Approval Times	26.07	25.66
Quarterly Mean Tentative Approval Times	40.69	39.37
Quarterly Median Tentative Approval Times	29.96	23.53

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

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