FDA,FY 2000 Performance Report for the Prescription Drug User Fee Act of 1992,APPENDIX C: List of Approved Applications

APPENDIX C: List of Approved Applications

This appendix updates the detailed review histories of the NDAs and PLA/BLAs submitted and approved under PDUFA. It shows approvals of all PDUFA-related submissions that took place in FY 00 as well as FY 99 approvals of FY 99 submissions. Earlier PDUFA approvals were listed in previous performance reports.

The following two tables summarize the review histories for all approved applications submitted from FY 95 through FY 99. The tables show the average first review, second review, and approval times. Note that times are in months, not all applications required a second review, and some required more than two reviews. The mean total approval times shown in the tables will increase in the future as additional applications are approved.

Approved Priority NDAs/BLAs

	1st Review		2nd Review			Total Approval Time
Receipt Cohort	N	FDA Review	n	Sponsor Response	FDA Review	Total Approval Time
FY95	21	8.7	10	6.0	3.3	13.2
FY96	31	7.4	13	2.6	3.7	11.6
FY97	23	6.3	10	4.4	3.6	9.5
FY98	31	6.1	12	1.5	2.7	8.1
FY99	25	6.3	7	1.6	2.1	7.3

Approved Standard NDAs/BLAs

	1st Review		2nd Review			Total Approval Time
Receipt Cohort	n	FDA Review	n	Sponsor Response	FDA Review	Total Approval Time
FY95	83	12.2	53	2.8	4.2	17.8
FY96	73	11.9	40	4.1	4.1	17.0
FY97	80	11.5	33	4.4	3.6	14.8
FY98	53	11.3	29	3.3	4.5	16.3
FY99	46	10.4	11	1.0	2.2	11.2

The remainder of this appendix shows the individual review histories. Approvals are grouped by submission year and priority designation and listed in order of total approval time. Review histories of all other PDUFA submissions approved prior to FY 99 can be found in the appendices of the earlier PDUFA Performance Reports which are available on FDA's web site (FDA Home)

Terms and Coding Used In Tables

(+) FY 99 approval of an FY 99 submission. These were not included in earlier PDUFA performance reports and are included here for completeness.
(**) Major amendment was received within 3 months of the action due date, which extended the review timeframes by 3 months.
Action Codes:	AE = Approvable AP = Approved NA = Not Approvable RL = Complete Response WD = Withdrawn

Table 1
FY 1999 Priority NDA and BLA Submissions Approved in FY 99 (+) and FY 00

	Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
	Generic Name	Sponsor	Approval Time (Months)		Review Goal Met

+	AMPRENAVIR (ORAL SOLUTION)	Glaxo Wellcome	4.2		Y
	SOMATROPIN - RDNA ORIGIN (SUSPENSION FOR INJECTION)	Genentech	5.8		Y
+	CYTARABINE	Skyepharma	5.9		Y
+	ROFECOXIB (ORAL SUSPENSION)	Merck Res	5.9		Y
+	ROFECOXIB (tableT)	Merck Res	5.9		Y
+	KETOTIFEN FUMARATE	Ciba Vision	5.9		Y
+	LEVONORGEStrEL	Womens Capital	5.9		Y
	OSELTAMIVIR PHOSPHATE	Roche	6.0		Y
	LEVOBETAXOLOL HYDROCHLORIDE	Alcon	6.0		Y
+	GANIRELIX ACETATE	Organon Inc	6.0		Y
+	ROSIGLITAZONE MALEATE	SKB Pharms	6.0		Y
+	PIOGLITAZONE HYDROCHLORIDE	Takeda Pharms	6.0		Y
+	AMPRENAVIR (CAPSULE)	Glaxo Wellcome	6.0		Y
+	PEMIROLAST POTASSIUM	Santen	6.0		Y
	BEXAROTENE	Ligand	6.2	FDA First Action: 6.0 (AE) Sponsor Response: 0.1 FDA Second Action: 0.1 (AP)	Y Y
	NITRIC OXIDE	INO	6.9¹	FDA First Action: 5.8 (AE) Sponsor Response: 0.7 FDA Second Action: 0.5 (AP)	Y Y
	ALOSEtrON HYDROCHLORIDE	Glaxo Wellcome	7.4		Y
	VERTEPORFIN	QLT	7.9	FDA First Action: 5.9 (AE) Sponsor Response: 0.4 FDA Second Action: 1.6 (AP)	Y Y
	NEDOCROMIL SODIUM	Allergan	8.2	FDA First Action: 6.0 (AE) Sponsor Response: 0.5 FDA Second Action: 1.8 (AP)	Y Y
	PNEUMOCOCCAL 7-VALENT CONJUGATE VACCINE (DIPHTHERIA CRM197 PROTEIN) (BLA)	Lederle Laboratories Division American Cyanamid Company	8.5	FDA First Action: 5.9 (RL) Sponsor Response: 0.7 FDA Second Action: 1.9 (AP)	Y Y
+	ZANAMIVIR	Glaxo Wellcome	8.9		Y
+	SIROLIMUS	Wyeth Ayerst Labs	9.0		Y
+	EPIRUBICIN HYDROCHLORIDE	Pharmacia and Upjohn	9.0		Y
	ASPIRIN/DIPYRIDAMOLE	Boehringer Pharms	11.2	FDA First Action: 6.0 (AE) Sponsor Response: 2.3 FDA Second Action: 3.0 (AP)	Y Y
	ATOVAQUONE/PROGUANIL HYDROCHLORIDE	Glaxo Wellcome	18.5	FDA First Action: 6.0 (AE) Sponsor Response: 6.7 FDA Second Action: 5.8 (AP)	Y Y

Table 2
FY 1999 Standard NDA and BLA Submissions Approved in FY 99 (+) and FY 00

	Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
	Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
	QUINAPRIL HYDROCHLORIDE/ HYDROCHLOROTHIAZIDE	Parke Davis	7.9²	FDA First Action: 6.9 (AE) Sponsor Response: 0.3 FDA Second Action: 0.6 (AP)	Y Y
	C13-UREA	Metabolic Solutions	9.0		Y
	AZELASTINE HYDROCHLORIDE	Asta Medica (US)	9.6		Y
	CLOtrIMAZOLE	Taro Pharms (US)	9.9		Y
	SEVELAMER HYDROCHLORIDE	Geltex	9.9		Y
	COLESEVELAM HYDROCHLORIDE (CAPSULE)	Sankyo Pharma Inc	9.9		Y
	COLESEVELAM HYDROCHLORIDE (tableT)	Sankyo Pharma Inc	9.9		Y
	LEVETIRACETAM	UCB Pharma	9.9		Y
	EStrADIOL/NORGESTIMATE	RW Johnson	9.9		Y
	ETHINYL EStrADIOL/NORETHINDRONE ACETATE	Parke Davis	9.9		Y
	TENECTEPLASE (BLA)	Genentech, Inc.	10.0		Y
+	MENOtrOPINS/LUTEINIZING HORMONE	Ferring Pharms	10.0		Y
+	CLINDAMYCIN PHOSPHATE	Pharmacia and Upjohn	10.0		Y
	EXEMESTANE	Pharmacia and Upjohn	10.0		Y
	NAPROXEN SODIUM/PSEUDOEPHEDRINE HYDROCHLORIDE	Bayer Cons	10.0		Y
	GABAPENTIN	Parke Davis	10.0		Y
	EFLORNITHINE HYDROCHLORIDE	Westwood Squibb	10.0		Y
+	EStrADIOL	RW Johnson	10.0		Y
	TESTOSTERONE	Unimed Pharms	10.0		Y
	LEUPROLIDE ACETATE	Alza	10.0		Y
	CALCIUM CHLORIDE	Abbott Labs	10.0		Y
	METFORMIN HYDROCHLORIDE /GLYBURIDE	Bristol Myers Squibb	10.0		Y
	CLARITHROMYCIN	Abbott Labs	10.0		Y
	NItrOGLYCERIN	Parke Davis	10.9	FDA First Action: 9.7 (AE) Sponsor Response: 0.6 FDA Second Action: 0.7 (AP)	Y Y
	CEFAZOLIN SODIUM	B Braun	11.1		Y
	CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE	AstraZeneca	11.3	FDA First Action: 9.7 (AE) Sponsor Response: 0.7 FDA Second Action: 0.9 (AP)	Y Y
	GATIFLOXACIN (tableT)	Bristol Myers Squibb	11.6		Y
	GATIFLOXACIN (INJECTION)	Bristol Myers Squibb	11.6		Y
	DILTIAZEM HYDROCHLORIDE	Biovail Labs	11.6	FDA First Action: 10.0 (AE) Sponsor Response: 0.9 FDA Second Action: 0.8 (AP)	Y Y
	SOMAtrOPIN - RDNA ORIGIN(SOLUTION FOR INJECTION)	Novo Nordisk Pharm	11.7		Y
	INSULIN GLARGINE	Aventis Pharms	11.9		Y
	CICLOPIROX	Aventis Pharms	12.0		Y
	DEXMEDETOMIDINE	Abbott Labs	12.0		Y
	INSULIN LISPRO 25% /INSULIN LISPRO PROTAMINE 75%	Lilly	12.0		Y
	INSULIN LISPRO 50% /INSULIN LISPRO PROTAMINE 50%	Lilly	12.0		Y
	MOXIFLOXACIN HYDROCHLORIDE	Bayer	12.0		Y
	trETINOIN	Johnson and Johnson	12.0		Y
	TAZAROTENE	Allergan	12.0		Y
	DOXERCALCIFEROL	Bone Care	12.0		Y
	METHYLPHENIDATE HYDROCHLORIDE	Alza	12.5	FDA First Action: 10.0 AE) Sponsor Response: .6 FDA Second Action: 1.9 (AP)	Y Y
	TINZAPARIN SODIUM	Dupont Pharma	12.5	FDA First Action: 10.0 (AE) Sponsor Response: 0.6 FDA Second Action: 1.9 (AP)	Y Y
	OLANZAPINE	Lilly	13.2	FDA First Action: 9.7 (AE) Sponsor Response: 1.2 FDA Second Action: 2.3 (AP)	Y Y
	CITALOPRAM HYDROBROMIDE	Forest Labs	13.6	FDA First Action: 10.0 (AE) Sponsor Response: 2.0 FDA Second Action: 1.7 (AP)	Y Y
	MELOXICAM	Boehringer Pharms	15.9	FDA First Action: 12.0 (AE) Sponsor Response: 2.0 FDA Second Action: 1.9 (AP)	Y Y
	SALMETEROL XINAFOATE /FLUTICASONE PROPIONATE	Glaxo Wellcome	17.0	FDA First Action: 10.1 (AE) Sponsor Response: 1.0 FDA Second Action: 6.0 (AP)	Y Y
	RIVASTIGMINE TARtrATE (ORAL SOLUTION)	Novartis Pharms	17.1	FDA First Action: 9.6 (AE) Sponsor Response: 1.4 FDA Second Action: 6.0 (AP)	Y Y

Table 3

FY 1998 Priority NDA and BLA Submissions Approved in FY 00

Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
BUDESONIDE (SUSPENSION FOR INHALATION)	AstraZeneca Pharms	26.6³	FDA First Action: 6.0 (AE) Sponsor Response: 2.7 FDA Second Action: 6.0 (AE) Sponsor Response: 12.0 FDA Third Action: 5.9 (AP)	Y Y Y

Table 4

FY 1998 Standard NDA and BLA Submissions Approved in FY 00

Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
OXCARBAZEPINE	Novartis Pharms	15.6	FDA First Action: 12.0 (AE) Sponsor Response: 1.7 FDA Second Action: 1.9 (AP)	Y Y
PROCHLORPERAZINE MALEATE	SKB Pharms	15.6⁴	FDA First Action: 4.6 (NA) Sponsor Response: 2.4 FDA Second Action: 5.8 (NA) Sponsor Response: 2.5 FDA Third Action: 1.8 (AE) Sponsor Response: 1.7 FDA Fourth Action: 5.3 (AP)	Y Y Y Y
CEVIMELINE HYDROCHLORIDE	Snowbrand	16.5	FDA First Action: 12.0 (AE) Sponsor Response: 2.5 FDA Second Action: 2.0 (AP)	Y Y
AMINOLEVULINIC ACID HYDROCHLORIDE	DUSA	17.1	FDA First Action: 11.9 (AE) Sponsor Response: 3.3 FDA Second Action: 2.0 (AP)	Y Y
PIPERONYL BUTOXIDE /PYRETHRINS	Pfizer	17.9	FDA First Action: 9.9 (AE) Sponsor Response: 2.0 FDA Second Action: 6.0 (AP)	Y Y
GADOPENTETATE DIMEGLUMINE	Berlex Labs	18.4	FDA First Action: 11.9 (AE) Sponsor Response: 0.6 FDA Second Action: 1.9 (AE) Sponsor Response: 0.1 FDA Third Action: 3.9 (AP)	Y Y Y
DOFETILIDE	Pfizer	18.8	FDA First Action: 11.9 (AE) Sponsor Response: 6.2 FDA Second Action: 0.7 (AP)	Y Y
PANTOPRAZOLE SODIUM	Wyeth Ayerst Labs	19.1	FDA First Action: 12.0 (AE) Sponsor Response: 1.1 FDA Second Action: 6.0 (AP)	Y Y
FEXOFENADINE HYDROCHLORIDE	Aventis Pharms	19.3	FDA First Action: 12.0 (AE) Sponsor Response: 1.4 FDA Second Action: 6.0 (AP)	Y Y
SERTRALINE HYDROCHLORIDE	Pfizer Pharms	19.7	FDA First Action: 12.0 (AE) Sponsor Response: 1.7 FDA Second Action: 6.0 (AP)	Y Y
INSULIN ASPART (RDNA ORIGIN)	Novo Nordisk Pharm	20.7	FDA First Action: 12.0 (AE) Sponsor Response: 2.7 FDA Second Action: 6.0 (AP)	Y Y
GADOVERSETAMIDE (GLASS VIAL)	Mallinckrodt	21.2	FDA First Action: 9.7 (NA) Sponsor Response: 5.5 FDA Second Action: 6.0 (AP)	Y Y
GADOVERSETAMIDE (PLASTIC SYRINGE)	Mallinckrodt	21.2	FDA First Action: 9.7 (NA) Sponsor Response: 5.5 FDA Second Action: 6.0 (AP)	Y Y
GADOVERSETAMIDE (PHARMACY BULK PACK)	Mallinckrodt	21.2	FDA First Action: 9.7 (NA) Sponsor Response: 5.5 FDA Second Action: 6.0 (AP)	Y Y
ENTACAPONE	Orion	21.5	FDA First Action: 11.9 (AE) Sponsor Response: 3.6 FDA Second Action: 6.0 (AP)	Y Y
OXYCODONE HYDROCHLORIDE	Roxane	23.0	FDA First Action: 11.8 (AE) Sponsor Response: 5.2 FDA Second Action: 6.0 (AP)	Y Y
MEQUINOL / trETINOIN	Bristol Myers Squibb	23.3	FDA First Action: 15.0 (AE) Sponsor Response: 7.6 FDA Second Action: 0.8 (AP)	Y** Y
ARTICAINE HYDROCHLORIDE / EPINEPHRINE	Deproco	24.2	FDA First Action: 10.0 (AE) Sponsor Response: 1.3 FDA Second Action: 1.9 (AE) Sponsor Response: 8.9 FDA Third Action: 2.0 (AP)	Y Y Y
ANTIHEMOPHILIC FACTOR (RECOMBINANT) (BLA)	Genetics Institute, Inc.	25.1	FDA First Action: 11.9 (RL) Sponsor Response: 4.2 FDA Second Action: 9.0 (AP)	Y N
BECLOMETHASONE DIPROPIONATE	3M Pharms	28.2	FDA First Action: 12.0 (AE) Sponsor Response: 3.2 FDA Second Action: 6.0 (AE) Sponsor Response: 0.4 FDA Third Action: 6.5 (AP)	Y Y N
FLUTICASONE PROPIONATE	Glaxo	30.0	FDA First Action: 12.0 (AE) Sponsor Response: 2.3 FDA Second Action: 6.0 (AE) Sponsor Response: 3.7 FDA Third Action: 6.0 (AP)	Y Y Y
DOCOSANOL	Avanir	31.1	FDA First Action: 12.0 (NA) Sponsor Response: 11.4 FDA Second Action: 5.9 (AE) Sponsor Response: 1.8 FDA Third Action: 0.0 (AP)	Y Y Y

Table 5

FY 1997 Standard NDA and BLA Submissions Approved in FY 00

Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
CHLORHEXIDINE GLUCONATE/ISOPROPYL ALCOHOL	Medi-Flex Hospital Products	18.0⁵	FDA First Action: 12.0 (NA) Sponsor Response: 22.8 FDA Second Action: 6.0 (AP)	Y Y
ZONISAMIDE	Dainippon Pharm	24.0⁶	FDA First Action: 12.0 (AE) Sponsor Response: 9.4 FDA Second Action: 6.0 (AE) Sponsor Response: 3.0 FDA Third Action: 6.0 (AP)	Y Y Y
BALSALAZIDE DISODIUM	Salix	30.8⁷	FDA First Action: 11.7 (AE) Sponsor Response: 15.3 FDA Second Action: 6.0 (AE) Sponsor Response: 2.0 FDA Third Action: 1.8 (AP)	Y Y Y
ADAPALENE	Galderma Labs LP	34.3	FDA First Action: 11.7 (NA) Sponsor Response: 14.0 FDA Second Action: 6.0 (AE) Sponsor Response: 0.9 FDA Third Action: 1.7 (AP)	Y Y Y
ARGATROBAN	Texas Biotech	34.5	FDA First Action: 8.7 (NA) Sponsor Response: 15.3 FDA Second Action: 6.1 (AE) Sponsor Response: 2.5 FDA Third Action: 1.9 (AP)	Y Y Y
RIVASTIGMINE TARtrATE (CAPSULE)	Novartis Pharms	36.5	FDA First Action: 15.0 (NA) Sponsor Response: 4.2 FDA Second Action: 6.0 (AE) Sponsor Response: 5.3 FDA Third Action: 6.0 (AP)	Y** Y Y

Table 6

FY 1996 Priority NDA and BLA Submissions Approved in FY 00

Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
MIFEPRISTONE	Population Council	18.0⁸	FDA First Action: 6.0 (AE) Sponsor Response: 35.0 FDA Second Action: 6.0 (AE) Sponsor Response: 1.4 FDA Third Action: 6.0 (AP)	Y Y Y

Table 7

FY 1996 Standard NDA and BLA Submissions Approved in FY 00

Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
PORACTANT ALFA	Dey Labs	32.0⁹	FDA First Action: 12.0 (NA) Sponsor Response: 8.0 FDA Second Action: 6.0 (AE) Sponsor Response: 8.5 FDA Third Action: 6.0 (AP)	Y Y Y
BUDESONIDE (NASAL SPRAY)	AstraZeneca	38.1	FDA First Action: 15.0 (AE) Sponsor Response: 4.1 FDA Second Action: 6.0 (AE) Sponsor Response: 3.7 FDA Third Action: 6.0 (AE) Sponsor Response: 1.0 FDA Third Action: 2.4 (AP)	Y** Y Y Y
TRIPTORELIN	Debio Recherche	47.7	FDA First Action: 12.0 (NA) Sponsor Response: 29.7 FDA Second Action: 6.0 (AP)	Y Y

Table 8

FY 1995 Standard NDA and BLA Submissions Approved in FY 00

Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
BCG Live (BLA)	BioChem Vaccines, Inc.	58.6	FDA First Action: 11.9 (NA) Sponsor Response: 3.5 FDA Second Action: 5.3 (NA) Sponsor Response: 1.6 FDA Third Action: 5.9 (NA) Sponsor Response: 3.3 FDA Fourth Action: 5.9 (RL) Sponsor Response: 15.4 FDA Fifth Action: 5.8 (AP)	Y Y Y Y Y

Table Notes

This application was originally submitted on 6/16/97 and was withdrawn on 9/17/97 because of insufficient data. It was resubmitted on 5/26/99. This date was used to calculate the total approval time.
This application was submitted on 2/14/90 and withdrawn on 10/27/92. It was resubmitted on 5/3/99. This date was used to calculate the total approval time.
The total approval time for this NDA was adjusted. The firm encountered a problem with the container when the product was shipped. Six months were excluded from the total approval time while the firm resolved the problem.
The total approval time for this NDA was adjusted. The firm first submitted this application as a supplement when it should have been submitted as an NDA. The time period from 10/1/97 to 6/18/98 was excluded from the total approval time.
The total approval time for this NDA was adjusted. The firm submitted new studies supporting a new indication. The time period from 2/20/98 to 1/14/00 was excluded from the total approval time.
The total approval time for this NDA was adjusted because of insufficient safety and efficacy data. The time period from 3/19/98 to 3/30/99 was excluded from the total approval time.
The total approval time for this NDA was adjusted. The firm submitted two pivotal studies using an active comparator that was not approved in the U.S. At FDA's request, the firm undertook additional evaluations to characterize the unapproved comparator. The time period from 3/24/99 to 9/24/99 was excluded from the total approval time.
The total approval time for this NDA was adjusted. The time period from 9/18/96 to 8/19/99 was excluded from the total approval time because the sponsor had to find a new manufacturer, the final study report for the US clinical trial was completed and submitted late in the review, and stability issues had to be addressed before the sponsor could resubmit the application for review. The time period from 2/18/00 to 3/31/00 was excluded from the total approval time while the sponsor prepared for a facilities reinspection
The total approval time for this NDA was adjusted. The time period until an acceptable inspection was received (9/3/98 to 5/19/99) was excluded from the total approval time.