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