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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Abbreviated New Drug Application (ANDA)
  7. Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance

GDUFA YEAR/
Actions This Month

18-Oct

18-Nov

18-Dec

19-Jan

19-Feb

19-Mar

19-Apr

19-May

19-Jun

19-Jul

19-Aug

19-Sep

FY-2019

Refuse to Receive (RTR) - Originals

7 4 4 1 6 6 6 3 5 2 3 * 47

Standard - GDUFA II

6 3 3 1 4 4 5 3 5 2 1 * 37

Priority - GDUFA II

1 1 1 0 2 2 1 0 0 0 2 * 10

GDUFA I

0 0 0 0 0 0 0 0 0 0 0 * 0

Acknowledgement - Original

54 90 66 69 86 95 82 103 59 52 87 * 843

Refuse to Receive (RTR) - PAS

0 0 1 1 0 0 0 0 0 0 1 * 3

Withdrawals  (all original ANDAs)

54 9 19 30 13 55 9 63 43 46 21 * 362

Approved ANDA

31 6 10 10 3 36 0 31 29 37 1 * 194

Unapproved ANDA

23 3 9 20 10 19 9 32 14 9 20 * 168

Withdrawals  (PAS)

9 2 3 4 11 8 4 7 11 8 8 * 75

Approvals ++++

110 99 69 82 83 89 93 83 45 61 66 55 935

First Cycle Approvals (included above)

24 11 10 17 12 11 10 10 8 13 10 * 136

Tentative Approvals ++++

22 32 39 24 19 17 18 12 17 14 13 9 236

First Cycle Tentative Approvals (included above)

5 6 2 4 2 2 2 1 2 3 0 * 29

Complete Responses (CR)

175 230 144 206 162 206 208 235 180 209 211 144 2310

Information Requests (IR)

372 364 290 357 303 396 389 385 312 370 318 * 3856

Originals

247 249 207 230 203 257 253 268 209 230 223 * 2576

Supplements

125 115 83 127 100 139 136 117 103 140 95 * 1280

Discipline Review Letters (DRL)

180 254 243 275 247 287 233 247 280 273 233 * 2752

Drug Master File Completeness Assessment (DMF CA)

55 58 48 30 58 64 68 71 57 61 43 * 613

GDUFA YEAR (Receipts)
Submissions This Month

18-Oct

18-Nov

18-Dec

19-Jan

19-Feb

19-Mar

19-Apr

19-May

19-Jun

19-Jul

19-Aug

19-Sep

FY-2019

Abbreviated New Drug Applications (ANDA) +

83 54 107 74 76 118 70 66 49 102 44 66 909

ANDA Amendments

225 187 199 180 204 196 200 192 179 190 172 * 2124

Major

134 97 90 76 90 86 109 110 96 117 87 * 1092

Minor

90 88 101 101 110 107 87 78 81 72 84 * 999

Unsolicited Amendments**

1 2 8 3 4 3 4 4 2 1 1 * 33

Pre-Submission Facility Correspondence

12 2 5 4 5 3 3 4 2 3 1 * 44

CBE Supplements

596 597 604 679 625 841 785 819 594 608 594 * 7342

PAS Supplements ++

76 65 67 69 59 65 85 70 67 95 95 * 813

DMFs - Type II

74 44 63 39 49 84 56 45 43 59 37 * 593

GDUFA YEAR (Receipts)

18-Oct

18-Nov

18-Dec

19-Jan

19-Feb

19-Mar

19-Apr

19-May

19-Jun

19-Jul

19-Aug

19-Sep

FY-2019

Controls +++

240 246 249 264 252 235 291 267 286 328 279 * 2937

Requests for Clarification

4 3 2 8 4 2 4 1 3 9 1 * 41

Post CR Meeting Requests This month

5 17 8 6 7 5 5 10 8 2 9 * 82

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.

* = This data requires additional verification and will be posted when available.
** = Unsolicited Amendments only include amendments submitted between review cycles.
+ = ANDA 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.

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications, including split approvals (final approvals of certain strengths in an ANDA at the same time that certain other strengths are tentatively approved) and subsequent tentative approvals of applications that have previously been tentatively approved.         
 

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