CDER FIRST ACTION PERFORMANCE FOR ORIGINAL EFFICACY SUPPLEMENTS

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CDER FIRST ACTION PERFORMANCE FOR ORIGINAL EFFICACY SUPPLEMENTS
Data as of FY 2005 Close-Out Cohort

CDER

		NO. SUBMITTED	RF or WF	UN	NO. FILED	NUMBER OF FIRST ACTIONS WITHIN GOAL						PDUFA GOALS	NUMBER OF FIRST ACTIONS OVERDUE
		NO. SUBMITTED	RF or WF	UN	NO. FILED	AP	AE	NA	WD	TOTAL			AP	AE	NA	WD	TOTAL
										NO.	PERCENT						NO.	PERCENT
FY93 as of 9/30/96		97	4	1	92	14	16	5	3	38	41%	no goal	10	18	21	5	54	59%

FY94 as of 3/31/97		106	6	14	86	18	29	14	5	66	77%	55%	10	5	5	0	20	23%

FY95 as of 3/31/97		94	4	13	77	27	34	10	2	73	95%	70%	0	2	2	0	4	5%

FY96 as of 2/28/98		117	3	9	105	60	32	7	4	103	98%	80%	0	2	0	0	2	2%

FY97 as of 11/30/98	P	11	0	1	10	8	1	0	1	10	100%	90%	0	0	0	0	0	0%
	S	147	2	9	136	84	20	22	8	134	99%	90%	2	0	0	0	2	1%
	Total	158	2	10	146	92	21	22	9	144	99%	90%	2	0	0	0	2	1%

FY98 as of 01/31/00	P	10	0	0	10	8	0	0	0	8	80%	90%	0	0	2	0	2	20%
	S	130	5	8	117	69	25	16	6	116	99%	90%	0	1	0	0	1	1%
	Total	140	5	8	127	77	25	16	6	124	98%	90%	0	1	2	0	3	2%

FY99 as of 12/31/00	P	15	0	0	15	9	1	2	1	13	87%	90%	0	2	0	0	2	13%
	S	138	8	8	122	69	18	13	4	104	85%	30% in 10 mos.*
	S	138	8	8	122	76	22	18	6	122	100%	90% in 12 mos.	0	0	0	0	0	0%
	Total	153	8	8	137

FY00 as of 10/31/01	P	18	0	0	18	15	2	0	1	18	100%	90%	0	0	0	0	0	0%
	S	178	7	14	157	63	50	22	7	142	90%	50% in 10 mos.*
	S	178	7	14	157	68	54	24	10	156	99%	90% in 12 mos.	0	1	0	0	1	1%
	Total	196	7	14	175

FY01 as of 09/30/02	P	7	0	0	7	4	2	0	0	6	86%	90%	0	0	1	0	1	14%
	S	158	7	3	147	67	41	13	14	135	92%	70% in 10 mos.*
	S	158	7	3	147	77	42	14	14	147	100%	90% in 12 mos.	0	0	0	0	0	0%
	Total	164	7	3	154

FY02 as of 02/29/04	P	31	0	0	31	13	9	6	3	31	100%	90% in 6 mos.	0	0	0	0	0	0%
	S	141	4	9	128	66	34	23	3	126	98%	90% in 10 mos.	2	0	0	0	2	2%
	Total	172	4	9	159

FY03 as of 10/31/04	P	35	0	0	35	24	8	3	0	35	100%	90% in 6 mos.	0	0	0	0	0	0%
	S	110	2	5	103	50	33	17	0	100	97%	90% in 10 mos.	3	0	0	0	3	3%
	Total	145	2	5	138

FY04 as of 8/31/06	P	52	0	4	48	32	7	3	2	44	92%	90% in 6 mos.	2	1	1	0	4	8%
	S	150	3	12	135	71	30	22	6	129	96%	90% in 10 mos.	2	1	3	0	6	4%
	Total	202	3	16	183

FY05 as of 10/31/06	P	35	1	0	34	21	10	3	0	34	100%	90% in 6 mos.	0	0	0	0	0	0%
	S	97	1	5	91	65	18	2	3	88	97%	90% in 10 mos.	3	0	0	0	3	3%
	Total	132	2	5	125

*The standard efficacy supplement 10-month goal and performance figures were a subset of the 12-month goal and performance figures. These supplements were only considered overdue when they exceeded the 12-month goal.

Abbreviations:

AP             Approved
AE             Approvable
NA            Not approvable
WD            Withdrawn
RF             Refuse to file
WF            Withdrawn from filing
UN            Unacceptable for filing because user fee not received

P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.

S -   Standard Review - The drug appears to have therapeutic qualities similar to those of one or more already marketed drugs.

Date created: September 18, 2006; Updated January 17, 2007