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  1. Generic Drug User Fee Amendments

Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTHOct-24Nov-24Dec-24Jan-25Feb-25Mar-25Apr-25May-25Jun-25Jul-25Aug-25Sep-25FY-2025
Approvals

62

58

67

63

 

 

 

 

 

 

 

 

250

First-Time Generics

6

4

8

9

 

 

 

 

 

 

 

 

27

First-Cycle Approvals

8

14

11

11

 

 

 

 

 

 

 

 

44

Imminent Actions

5

6

9

13

 

 

 

 

 

 

 

 

33

Tentative Approvals

20

17

25

27

 

 

 

 

 

 

 

 

89

First-Cycle Tentative Approvals

3

3

3

5

 

 

 

 

 

 

 

 

14

Imminent Actions

5

4

6

7

 

 

 

 

 

 

 

 

22

Complete Responses

118

87

118

123

 

 

 

 

 

 

 

 

446

Original ANDAs Refuse-to-Receive

0

2

3

1

 

 

 

 

 

 

 

 

6

Standard

0

2

2

0

 

 

 

 

 

 

 

 

4

Priority

0

0

1

1

 

 

 

 

 

 

 

 

2

Original Acknowledgements

81

59

14

62

 

 

 

 

 

 

 

 

216

Withdrawals

17

5

10

11

 

 

 

 

 

 

 

 

43

Approved ANDAs

9

0

2

0

 

 

 

 

 

 

 

 

11

Unapproved ANDAs

8

5

8

11

 

 

 

 

 

 

 

 

32

PAS Approvals

160

86

133

138

 

 

 

 

 

 

 

 

517

PASs given Refuse-to-Receive

1

2

1

0

 

 

 

 

 

 

 

 

4

PAS Withdrawals

6

16

4

8

 

 

 

 

 

 

 

 

34

Information Requests

407

344

343

356

 

 

 

 

 

 

 

 

1450

Originals

204

195

194

195

 

 

 

 

 

 

 

 

788

Supplements

203

149

149

161

 

 

 

 

 

 

 

 

662

Discipline Review Letters

168

128

100

160

 

 

 

 

 

 

 

 

556

DMF Completeness Assessments

37

26

34

47

 

 

 

 

 

 

 

 

144

Reclassifications of a Facility-Based Major CRL Granted

4

7

5

5

 

 

 

 

 

 

 

 

21

Reclassifications of a Facility-Based Major CRL Denied

0

1

0

1

 

 

 

 

 

 

 

 

2

Pending ANDAs Awaiting FDA Action +

1480

1440

1438

1384

 

 

 

 

 

 

 

 

--

ANDAs Awaiting Applicant Action ++

1941

1928

1929

1956

 

 

 

 

 

 

 

 

--

Tentative Approvals +++

528

526

538

544

 

 

 

 

 

 

 

 

--

Complete Responses ++++

1413

1402

1391

1412

 

 

 

 

 

 

 

 

--

 

SUBMISSIONS BY MONTHOct-24Nov-24Dec-24Jan-25Feb-25Mar-25Apr-25May-25Jun-25Jul-25Aug-25Sep-25FY-2025
ANDAs *

14

18

80

39

 

 

 

 

 

 

 

 

151

Complex Products

2

10

18

1

 

 

 

 

 

 

 

 

31

Amendments

172

158

186

166

 

 

 

 

 

 

 

 

682

Major

54

50

65

53

 

 

 

 

 

 

 

 

222

Minor

60

58

72

60

 

 

 

 

 

 

 

 

250

Unsolicited

58

50

49

53

 

 

 

 

 

 

 

 

210

Requests for Reclassification of a Facility-Based Major CRL Amendment

11

5

10

3

 

 

 

 

 

 

 

 

29

Pre-Submission Facility Correspondences

4

6

2

4

 

 

 

 

 

 

 

 

16

Supplements

911

812

875

895

 

 

 

 

 

 

 

 

3493

CBEs

762

665

712

735

 

 

 

 

 

 

 

 

2874

PASs **

149

147

163

160

 

 

 

 

 

 

 

 

619

DMF Payments

27

22

32

30

 

 

 

 

 

 

 

 

111

Controlled Correspondence ***

318

231

293

348

 

 

 

 

 

 

 

 

1190

Level 1

276

196

241

299

 

 

 

 

 

 

 

 

1012

Level 2

42

35

52

49

 

 

 

 

 

 

 

 

178

Controlled Correspondence Requests for Clarification

0

0

0

1

 

 

 

 

 

 

 

 

1

Product Development Meeting

10

12

8

9

 

 

 

 

 

 

 

 

39

Pre-Submission Meetings

1

0

2

0

 

 

 

 

 

 

 

 

3

PSG Teleconferences

1

1

0

0

 

 

 

 

 

 

 

 

2

Pre-Submission PSG Meetings

0

0

0

0

 

 

 

 

 

 

 

 

0

Post-Submission PSG Meetings

0

0

0

0

 

 

 

 

 

 

 

 

0

Mid Cycle Review Meetings

0

0

1

1

 

 

 

 

 

 

 

 

2

Enhanced Mid Cycle Review Meetings

0

1

1

1

 

 

 

 

 

 

 

 

3

Post-CRL Clarification-Only Teleconference

5

8

7

3

 

 

 

 

 

 

 

 

23

Post-CRL Scientific Meeting

2

3

2

1

 

 

 

 

 

 

 

 

8

 

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

 

 

 

Quarterly Median Approval Times

26.22

 

 

 

Quarterly Mean Tentative Approval Times

37.75

 

 

 

Quarterly Median Tentative Approval Times

25.13

 

 

 

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

Previous Quarterly Reports

 

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