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	5	52
Standard - GDUFA II	6	3	3	1	4	4	5	3	5	2	1	3	40
Priority - GDUFA II	1	1	1	0	2	2	1	0	0	0	2	2	12
GDUFA I	0	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	70	913
Refuse to Receive (RTR) - PAS	0	0	1	1	0	0	0	0	0	0	1	0	3
Withdrawals (all original ANDAs)	54	9	19	30	13	55	9	63	43	46	21	26	388
Approved ANDA	31	6	10	10	3	36	0	31	29	37	1	1	195
Unapproved ANDA	23	3	9	20	10	19	9	32	14	9	20	25	193
Withdrawals (PAS)	9	2	3	4	11	8	4	7	11	8	8	7	82
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	11	147
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	1	30
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	306	4162
Originals	247	249	207	230	203	257	253	268	209	230	223	197	2773
Supplements	125	115	83	127	100	139	136	117	103	140	95	109	1389
Discipline Review Letters (DRL)	180	254	243	275	247	287	233	247	280	273	233	245	2997
Drug Master File Completeness Assessment (DMF CA)	55	58	48	30	58	64	68	71	57	61	43	49	662

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	186	2310
Major	134	97	90	76	90	86	109	110	96	117	87	97	1189
Minor	90	88	101	101	110	107	87	78	81	72	84	87	1086
Unsolicited Amendments**	1	2	8	3	4	3	4	4	2	1	1	2	35
Pre-Submission Facility Correspondence	12	2	5	4	5	3	3	4	2	3	1	7	51
CBE Supplements	596	597	604	679	625	841	785	819	594	608	594	675	8017
PAS Supplements ++	76	65	67	69	59	65	85	70	67	95	95	76	889
DMFs - Type II	74	44	63	39	49	84	56	45	43	59	37	57	650

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	269	3206
Requests for Clarification	4	3	2	8	4	2	4	1	3	9	1	6	47
Post CR Meeting Requests This month	5	17	8	6	7	5	5	10	8	2	9	4	86

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.

U.S. Food and Drug Administration

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

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