Generic Drugs Program Monthly and Quarterly Activities Report

With the start of GDUFA III in FY 2023, the Generic Drugs Program monthly and quarterly activities reports were combined into one report. Also, reported metrics have been updated to reflect reporting requirements outlined in the GDUFA III Commitment Letter.

ACTIONS BY MONTH	Oct-22	Nov-22	Dec-22	Jan-23	Feb-23	Mar-23	Apr-23	May-23	Jun-23	Jul-23	Aug-23	Sep-23	FY-2023
Approvals	58	60	52	56	46	96	64	63	76	69	98	44	782
First-Time Generics	1	3	7	4	5	4	5	6	8	18	22	6	89
First-Cycle Approvals	14	13	10	9	6	16	11	13	13	10	23	10	148
Imminent Actions	7	10	7	9	6	14	4	7	5	10	14	6	99
Tentative Approvals	13	13	7	20	21	21	10	18	12	15	12	10	172
First-Cycle Tentative Approvals	0	2	1	2	0	3	2	3	1	2	2	2	20
Imminent Actions	1	3	3	1	3	6	2	5	3	3	4	1	35
Complete Responses	148	120	124	140	141	161	92	105	120	104	118	103	1476
Original ANDA Refuse to Receive	1	2	5	5	3	4	3	2	4	1	2	1	33
Standard	1	2	4	3	2	3	1	1	4	1	1	1	24
Priority	0	0	1	2	1	1	2	1	0	0	1	0	9
Original Acknowledgements	26	97	40	83	76	50	47	93	51	45	53	60	721
Withdrawals	3	9	11	28	9	23	22	4	23	13	16	11	172
Approved ANDA	0	0	7	0	0	12	14	0	1	7	0	0	41
Unapproved ANDA	3	9	4	28	9	11	8	4	22	6	16	11	131
PAS Approvals	117	96	103	94	98	159	120	114	118	115	125	124	1383
PAS Refuse to Receives	0	0	2	1	1	0	0	1	0	1	0	0	6
PAS Withdrawals	5	7	7	5	8	8	6	9	5	2	4	1	67
Information Requests	297	324	297	326	325	385	325	322	342	298	346	304	3891
Originals	178	209	144	170	194	232	176	200	190	173	176	174	2216
Supplements	119	115	153	156	131	153	149	122	152	125	170	130	1675
Discipline Review Letters	224	201	210	179	146	297	156	195	225	193	172	257	2455
DMF Completeness Assessment	45	14	23	49	31	52	26	35	25	24	37	36	397
Reclassification of a Facility-Based Major CRL Granted	0	0	1	1	0	6	0	3	0	2	1	4	18
Reclassification of a Facility-Based Major CRL Denied	0	1	3	0	0	0	0	0	0	0	0	0	4
Pending ANDAs Awaiting FDA Action +	1584	1615	1678	1646	1609	1586	1638	1647	1593	1586	1545	1531	--
ANDAs Awaiting Applicant Action ++	2177	2144	2108	2111	2134	2135	2084	2064	2060	2039	2018	2023	--
Tentative Approvals +++	469	470	466	473	485	484	477	475	481	487	487	483	--
Complete Responses ++++	1708	1674	1642	1638	1649	1651	1607	1589	1579	1552	1531	1540	--

SUBMISSIONS BY MONTH	Oct-22	Nov-22	Dec-22	Jan-23	Feb-23	Mar-23	Apr-23	May-23	Jun-23	Jul-23	Aug-23	Sep-23	FY-2023
ANDAs *	34	76	109	41	38	112	44	58	55	36	57	73	733
Complex Products	6	8	20	5	8	15	9	9	11	8	7	15	121
Amendments	187	247	246	194	211	255	219	236	229	234	217	183	2658
Major	77	97	75	66	88	89	75	72	78	74	65	49	905
Minor	55	65	82	59	58	67	61	63	49	49	61	47	716
Unsolicited	55	85	89	69	65	99	83	101	102	111	91	87	1037
Requests for Reclassification of a Facility-Based Major CRL Amendment	13	8	0	4	7	5	2	2	1	3	9	7	61
Pre-Submission Facility Correspondence	7	4	4	3	1	2	0	4	7	4	3	8	47
Supplements	693	727	676	688	727	921	839	1183	1012	874	916	979	10235
CBE	584	574	566	591	623	757	712	986	866	754	775	846	8634
PAS **	109	153	110	97	104	164	127	197	146	120	141	133	1601
DMF Payments	14	22	33	33	28	31	17	23	15	27	43	105	391
Controlled Correspondence ***	267	303	277	286	296	378	278	349	313	325	284	312	3668
Level 1	235	280	253	255	271	336	240	314	280	294	249	276	3283
Level 2	32	23	24	31	25	42	38	35	33	31	35	36	385
Controlled Correspondence Requests for Clarification	2	2	3	1	5	0	2	1	1	2	3	0	22
Product Development Meetings	8	4	13	3	8	7	11	8	11	12	7	8	100
Pre-Submission Meetings	0	3	0	0	0	0	0	3	1	1	1	0	9
PSG Teleconferences	0	0	0	0	0	0	0	1	0	0	0	1	2
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	0	0	0	0	0	0	0	1	0	0	1
Enhanced Mid Cycle Review Meetings	0	0	0	0	0	0	0	0	1	0	0	0	1
Post-CRL Clarification-Only Teleconferences	7	5	9	7	4	6	7	5	6	3	5	2	66
Post-CRL Scientific Meetings	3	0	2	2	2	1	1	0	3	0	4	2	20

APPROVAL TIMES BY QUARTER ^	Q1 (Oct - Dec 2022)	Q2 (Jan- Mar 2023)	Q3 (Apr - Jun 2023)	Q4 (Jul - Sept 2023)
Quarterly Mean Approval Times	28.82	38.11	35.09	34.65
Quarterly Median Approval Times	20.60	23.45	23.10	20.96
Quarterly Mean Tentative Approval Times	25.32	39.88	30.09	41.16
Quarterly Median Tentative Approval Times	20.31	36.76	25.36	24.74

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:
ANDA = Abbreviated New Drug Application
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. 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 Action represent a snapshot in time for the status of distinct original ANDAs. 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 in the United States. 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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