Activities Report of the Generic Drug Program (FY 2018)
GDUFA YEAR/Actions This Month |
17-Oct |
17-Nov |
17-Dec |
18-Jan |
18-Feb |
18-Mar |
18-Apr |
18-May |
18-Jun |
18-Jul |
18-Aug |
18-Sep |
FY-2018 |
Refuse to Receive (RTR) - Originals |
10 |
30 |
18 |
11 |
9 |
9 |
5 |
8 |
11 |
5 |
7 |
4 |
127 |
Standard - GDUFA II |
0 |
1 |
2 |
6 |
6 |
1 |
2 |
4 |
4 |
1 |
4 |
2 |
33 |
Priority - GDUFA II |
0 |
5 |
5 |
3 |
3 |
6 |
3 |
4 |
7 |
3 |
3 |
2 |
44 |
GDUFA I |
10 |
24 |
11 |
2 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
50 |
Acknowledgement - Original |
66 |
161 |
63 |
51 |
105 |
86 |
57 |
136 |
72 |
70 |
84 |
103 |
1054 |
Refuse to Receive (RTR) - PAS |
1 |
1 |
1 |
2 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
8 |
Withdrawals (all original ANDAs) |
37 |
96 |
13 |
90 |
146 |
43 |
12 |
29 |
27 |
11 |
44 |
58 |
606 |
Approved ANDA |
26 |
85 |
0 |
67 |
129 |
23 |
3 |
18 |
12 |
0 |
31 |
48 |
442 |
Unapproved ANDA |
11 |
11 |
13 |
23 |
17 |
20 |
9 |
11 |
15 |
11 |
13 |
10 |
164 |
Withdrawals (PAS) |
5 |
5 |
9 |
4 |
11 |
10 |
8 |
6 |
0 |
7 |
9 |
7 |
81 |
Approvals |
87 |
84 |
78 |
25 |
32 |
57 |
66 |
67 |
74 |
96 |
53 |
62 |
781 |
First Cycle Approvals (included above) |
26 |
13 |
20 |
11 |
7 |
7 |
13 |
7 |
11 |
16 |
6 |
5 |
142 |
Tentative Approvals |
14 |
23 |
20 |
6 |
5 |
11 |
16 |
19 |
18 |
30 |
15 |
13 |
190 |
First Cycle Tentative Approvals (included above) |
2 |
4 |
1 |
1 |
1 |
3 |
1 |
2 |
3 |
4 |
2 |
0 |
24 |
Complete Responses (CR) |
325 |
240 |
242 |
307 |
185 |
159 |
142 |
185 |
217 |
357 |
156 |
133 |
2648 |
Information Requests (IR) |
267 |
328 |
263 |
457 |
390 |
429 |
362 |
449 |
391 |
325 |
436 |
355 |
4452 |
Originals |
185 |
231 |
190 |
360 |
297 |
321 |
280 |
344 |
283 |
217 |
323 |
261 |
3292 |
Supplements |
82 |
97 |
73 |
97 |
93 |
108 |
82 |
105 |
108 |
108 |
113 |
94 |
1160 |
Discipline Review Letters (DRL) |
108 |
81 |
88 |
35 |
80 |
224 |
149 |
216 |
322 |
198 |
248 |
299 |
2048 |
Drug Master File Completeness Assessment (DMF CA) |
50 |
59 |
48 |
64 |
47 |
89 |
49 |
48 |
45 |
49 |
53 |
58 |
659 |
GDUFA YEAR (Receipts)Submissions This Month |
17-Oct |
17-Nov |
17-Dec |
18-Jan |
18-Feb |
18-Mar |
18-Apr |
18-May |
18-Jun |
18-Jul |
18-Aug |
18-Sep |
FY-2018 |
Abbreviated New Drug Applications (ANDA) + |
65 |
50 |
131 |
91 |
56 |
139 |
83 |
57 |
85 |
91 |
97 |
99 |
1044 |
ANDA Amendments |
156 |
163 |
168 |
139 |
177 |
191 |
218 |
232 |
202 |
241 |
271 |
199 |
2357 |
Major |
60 |
71 |
73 |
58 |
77 |
84 |
98 |
107 |
108 |
117 |
123 |
102 |
1078 |
Minor |
88 |
90 |
94 |
80 |
100 |
105 |
115 |
124 |
92 |
120 |
146 |
96 |
1250 |
Unsolicited Amendment |
8 |
2 |
1 |
1 |
0 |
2 |
5 |
1 |
2 |
4 |
2 |
1 |
29 |
Pre-Submission Facility Correspondence |
5 |
1 |
5 |
8 |
9 |
6 |
5 |
6 |
1 |
6 |
7 |
8 |
67 |
CBE Supplements |
580 |
657 |
475 |
453 |
496 |
361 |
651 |
574 |
675 |
512 |
575 |
479 |
6488 |
PAS Supplements |
83 |
46 |
65 |
54 |
50 |
179 |
200 |
92 |
70 |
94 |
92 |
78 |
1103 |
DMFs - Type II |
64 |
56 |
81 |
66 |
31 |
85 |
46 |
43 |
41 |
53 |
55 |
62 |
683 |
GDUFA YEAR (Receipts) |
17-Oct |
17-Nov |
17-Dec |
18-Jan |
18-Feb |
18-Mar |
18-Apr |
18-May |
18-Jun |
18-Jul |
18-Aug |
18-Sep |
FY-2018 |
Controls ++ |
233 |
252 |
239 |
238 |
238 |
228 |
250 |
252 |
266 |
264 |
253 |
220 |
2933 |
Requests for Clarification |
0 |
0 |
4 |
0 |
0 |
3 |
1 |
2 |
6 |
0 |
5 |
5 |
26 |
GDUFA Post CR Meeting Requests +++ |
214 |
225 |
227 |
236 |
253 |
259 |
259 |
264 |
268 |
273 |
282 |
285 |
|
Post CR Meeting Requests This month |
8 |
11 |
2 |
9 |
17 |
6 |
0 |
5 |
4 |
5 |
9 |
3 |
79 |
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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