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Activities Report of the Generic Drugs Program (FY 2015)
GDUFA YEAR/Actions This Month
14-Oct
14-Nov
14-Dec
15-Jan
15-Feb
15-Mar
15-Apr
15-May
15-Jun
15-Jul
15-Aug
15-Sep
FY-2015
Refuse to Receive (RTR) +
12
11
15
30
27
13
11
15
20
13
19
50
236
Withdrawals
6
12
2
11
7
17
23
11
21
16
18
26
170
Approvals
45
28
29
25
27
19
49
47
57
47
58
61
492
Tentative Approvals
10
7
5
5
13
6
19
13
10
12
6
14
120
Complete Responses (CR) +
43
76
96
104
108
94
115
97
116
134
96
101
1180
Drug Master File Completeness Assessment (DMF CA)
124
55
71
92
86
55
76
62
65
54
35
105
880
GDUFA YEAR (Receipts)Submissions This Month
14-Oct
14-Nov
14-Dec
15-Jan
15-Feb
15-Mar
15-Apr
15-May
15-Jun
15-Jul
15-Aug
15-Sep
FY-2015
Abbreviated New Drug Applications (ANDA) ++
50
27
43
27
29
57
58
49
39
52
33
75
539
CBE Supplements +
473
385
434
411
420
439
413
474
472
425
549
466
5361
PAS Supplements +
45
22
51
33
37
55
38
48
37
41
28
45
480
GDUFA YEAR/ (Receipts)Amendments
14-Oct
14-Nov
14-Dec
15-Jan
15-Feb
15-Mar
15-Apr
15-May
15-Jun
15-Jul
15-Aug
15-Sep
FY-2015
Originals (Pre FY15) Administrative
119
228
388
339
429
372
Originals (Pre FY15) Solicited (CR, ECD/IR)
86
80
178
320
582
503
Originals (Pre FY15) Unsolicited
398
229
108
118
84
130
Originals (FY15) Administrative
1
21
20
30
21
23
Originals (FY15) Tier 1
0
0
0
0
0
1
Originals (FY15) Tier 2
0
0
0
0
0
1
Originals (FY15) Tier 3
0
0
0
0
0
0
Originals (FY15) ECD/IR
0
7
4
43
37
54
PAS Supplements (Pre FY15) Administrative
5
21
15
18
14
9
PAS Supplements (Pre FY15) Solicited (CR, ECD/IR)
47
35
88
45
42
53
PAS Supplements (Pre FY15) Unsolicited
43
21
11
11
10
9
PAS Supplements (FY15) Administrative
1
6
3
7
2
7
PAS Supplements (FY15) Tier 1
0
0
0
0
0
1
PAS Supplements (FY15) Tier 2
0
0
0
0
1
0
PAS Supplements (FY15) Tier 3
0
0
0
0
0
0
PAS Supplements (FY15) ECD/IR
0
0
3
4
11
28
CBE Amendments (all years together)
61
34
29
72
71
101
GDUFA YEAR (Receipts)
14-Oct
14-Nov
14-Dec
15-Jan
15-Feb
15-Mar
15-Apr
15-May
15-Jun
15-Jul
15-Aug
15-Sep
FY-2015
Controls +++
112
86
111
115
104
140
136
124
141
170
127
106
1472
GDUFA Post CR Meeting Requests ++++
84
89
96
105
113
123
129
132
134
137
140
140
Post CR Meeting Requests This month
0
5
7
9
8
10
6
3
2
3
3
0
56
+ = Revised to reflect more accurate counting by the GDRP. For example RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons. ++ = Starting FY15 ANDA Original Receipts are reported as raw receipts (versus filed receipts). +++ = FY 15 Controls have been revised to count only those requests appropriate for a control. ++++ = Cumulative and NOT specific to the month. DMF raw receipts have been eliminated since DMF Completeness Assessments present a more accurate indication of workload. Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes. Note: Amendment metrics for April, May, June, July, August and September will be forthcoming
