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										196
Complex Products	5	13	23										41
Amendments	211	194	213										618
Major	55	52	69										176
Minor	50	46	59										155
Unsolicited	106	96	85										287
Requests for Reclassification of a Facility-Based Major CRL Amendment	4	6	12										22
Pre-Submission Facility Correspondence	11	5	5										21
Supplements	947	967	778										2692
CBE	818	832	640										2290
PAS**	129	135	138										402
DMF Payments	8	22	28										58
Controlled Correspondence ***	264	257	213										734
Level 1	235	224	190										649
Level 2	29	33	23										85
Controlled Correspondence Requests for Clarification	1	1	1										3
Product Development Meeting	7	4	9										20
Pre-Submission Meeting	0	0	0										0
PSG Teleconference	0	0	0										0
Pre-Submission PSG Meetings	0	0	0										0
Post-Submission PSG Meeting	0	0	0										0
Mid Cycle Review Meeting	1	0	0										1
Enhanced Mid Cycle Review Meeting	2	0	0										2
Post-CRL Clarification-Only Teleconference	3	7	11										21
Post-CRL Scientific Meeting	1	1	2										4

 

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
Quarterly Median Approval Times	26.07
Quarterly Mean Tentative Approval Times	40.69
Quarterly Median Tentative Approval Times	29.96

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