Drugs

Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance

GDUFA YEAR/Actions This Month17-Oct17-Nov17-Dec18-Jan18-Feb18-Mar18-Apr18-May18-Jun18-Jul18-Aug18-SepFY-2018
Refuse to Receive (RTR) - Originals1030 18 11  99 5 11 5 * 116
Standard - GDUFA II01 2 6  61 2 4 4 1  * 27
Priority - GDUFA II05 5 3  36 3 4 7 3  * 39
GDUFA I1024 11 2  02 0 0 0 1  * 50
Acknowledgement - Original66161 63 51  10586  57 136 72 70  * 867
Refuse to Receive (RTR) - PAS11 1 2  20 1 0 0 0  * 8
Withdrawals (all original ANDAs)3796 13 90  14643 12 29 27 11  * 504
Approved ANDA2685 0 67  12923 3 18 12 0  * 363
Unapproved ANDA1111 13 23  1720 9 11 15 11  * 141
Withdrawals  (PAS)55 9 4  1110 8 6 0 7  * 65
 Approvals8784 78 25  3257  66 67 74 96  53 719
First Cycle Approvals (included above) 2613 20 11  77 13 7 11 16  * 131
Tentative Approvals1423 20 6  511  16 19 18 30  15 177
First Cycle Tentative Approvals (included above)24 1 1  13 1 2 3 4  * 22
Complete Responses (CR)325240242 307185159  142 185 217 357  156 2515
Information Requests (IR)267328263 457 390429 362 449 391 325  * 3661
Originals 185231190 360 297 321 280 344 283 217  * 2708
 Supplements 82 97 73 97 93 108 82 105 108 108  * 953
Discipline Review Letters (DRL)1088188 35  80224 149 216 322 198  * 1501
Drug Master File Completeness Assessment (DMF CA)505948 64  4789 4948 45 49  * 548
GDUFA YEAR (Receipts)Submissions This Month17-Oct17-Nov17-Dec18-Jan18-Feb18-Mar18-Apr18-May18-Jun18-Jul18-Aug18-SepFY-2018
Abbreviated New Drug Applications (ANDA) +6550 131 91  56139 83 57 85 91 97 945
ANDA Amendments156163 168 139  177191 218 232 202 241  * 1887
Major6071 73 58  7784 98 107 108 117  * 853
Minor8890 94 80  100105 115 124 92 120  * 1008
Unsolicited Amendment82 1 1  02 5 1 2 4  * 26
Pre-Submission Facility Correspondence51 5 8  96 5 6 1 6  * 52
CBE Supplements580657 475 453  496361 651 574 675 512  * 5434
PAS Supplements8346 65 54  50179 200 92 70 94  * 933
DMFs - Type II6456 81 66  3185 46 43 41 53  * 566
GDUFA YEAR (Receipts)17-Oct17-Nov17-Dec18-Jan18-Feb18-Mar18-Apr18-May18-Jun18-Jul18-Aug18-SepFY-2018
Controls ++233252 239 238  238228 250 252 266 264  * 2460
Requests for Clarification00 4 0  03 1 2 6 0  * 16
GDUFA Post CR Meeting Requests +++214225 227 236  253259 259 264 268 273  *  
Post CR Meeting Requests This month811 2 9  176 0 5 4 5  * 67

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. 
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).    
++ = Controls count only those requests deemed appropriate for a control.     
+++ = Cumulative and NOT specific to the month.     

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Page Last Updated: 09/13/2018
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