Appendix D (List of Approved Applications): PDUFA FY 98 Performance Report to Congress

APPENDIX D: LIST OF APPROVED APPLICATIONS

This appendix updates the detailed review histories of the NDAs and BLAs submitted and approved under PDUFA. It shows approvals of FY 93 through FY 97 submissions that took place this year as well as FY 97 approvals of FY 97 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 93 through FY 97. 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 for the FY 96 and FY 97 submissions will increase in the future as additional applications are approved.

Approved Priority NDAs and BLAs

	1st Review		2nd Review			Total Approval Time
Submission Year	n	FDA Review	n	Sponsor Response	FDA Review	Total Approval Time
FY93	13	9.8	5	5.1	3.0	14.2
FY94	13	9.8	8	1.6	3.4	12.9
FY95	21	8.7	10	6.0	3.3	13.2
FY96	30	7.3	12	3.0	3.5	11.3
FY97	20	6.2	7	1.7	3.2	7.9

Approved Standard NDAs and BLAs

	1st Review		2nd Review			Total Approval Time
Submission Year	n	FDA Review	n	Sponsor Response	FDA Review	Total Approval Time
FY93	59	15.0	42	5.5	4.7	25.7
FY94	65	12.7	50	5.3	4.4	22.9
FY95	82	12.2	52	2.8	4.2	17.3
FY96	66	11.9	33	2.5	3.7	15.1
FY97	59	11.4	12	1.4	2.6	12.4

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 98 can be found in the appendices of the earlier PDUFA Performance Reports which are available on FDA's Internet home page:

Third Annual Performance Report
http://www.fda.gov/ope/pdufa/report95.html
Third Annual Financial Report (1.1 Mb pdf file)
http://www.fda.gov/ope/95financ.pdf
Fourth Annual Performance Report
http://www.fda.gov/ope/pdufa/report96/
Final Performance Report
http://www.fda.gov/ope/pdufa/report97/pdufa97.htm
PDUFA II Five-Year Plan
http://www.fda.gov/oc/pdufa2/5yrplan.html

TERMS AND CODING USED IN TABLES

	FY 97 approval of an FY 97 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.
t	Tentative Approval
	Action Codes:	NA = Not Approvable AE = Approvable AP = Approval RL = Complete Response

Table 1
FY 97 Priority NDA and BLA Submissions Approved in FY 97 () and FY 98

Generic Name Sponsor Approval Time (Months) Review
Goal
Met

Total
Time Resubmissions
(if necessary)

NELFINAVIR MESYLATE Agouron 2.6 Y

NELFINAVIR MESYLATE (PEDIATRIC) Agouron 2.6 Y

LAMIVUDINE/ZIDOVUDINE Glaxo Wellcome 3.9 Y

TOBRAMYCIN Pathogenesis 5.4 Y

REPAGLINIDE Novo Nordisk Pharm 5.7 Y

SAQUINAVIR Roche 5.9 Y

SILDENAFIL CITRATE Pfizer-Agri 5.9 Y

DACLIZUMAB (BLA) Hoffmann-La Roche, Inc. 6.0 Y

PROGESTERONE Columbia Res Labs 6.0 Y

RALOXIFENE HYDROCHLORIDE Lilly 6.0 Y

CLOPIDOGREL BISULFATE Sanofi Pharms 6.7 FDA First Action: 6.0 (AE)
Sponsor Response: 0.2
FDA Second Action: 0.5 (AP) Y

Y

RITUXIMAB FORMULATED BULK (BLA) IDEC Pharmaceuticals Corporation 8.7 FDA First Action: 5.7 (NA)
Sponsor Response: 1.6
FDA Second Action: 1.4 (AP) Y

Y

PACLITAXEL Baker Norton 8.8 Y ^t

GLUCAGON HYDROCHLORIDE RECOMBINANT Novo Nordisk Pharm 8.9 Y

AMPHOTERICIN B LIPOSOME Fujisawa USA 8.9 Y

RITUXIMAB (BLA) Genentech, Inc. 8.9 FDA First Action: 6.0 (NA)
Sponsor Response: 1.0
FDA Second Action: 2.0 (AP) Y

Y

SACROSIDASE Orphan Medcl 11.1 FDA First Action: 6.0 (AE)
Sponsor Response: 1.3
FDA Second Action: 3.8 (AP) Y

Y

TECHNETIUM TC 99M APTICIDE Diatide 12.8 FDA First Action: 6.0 (AE)
Sponsor Response: 0.8
FDA Second Action: 6.0 (AP) Y

Y

LEPIRUDIN Hoechst Marion Rssl 14.1 FDA First Action: 8.3 (AE)
Sponsor Response: 2.5
FDA Second Action: 3.4 (AP) Y

Y

THALIDOMIDE Celgene 18.8 FDA First Action: 9.0 (AE)
Sponsor Response: 4.3
FDA Second Action: 5.6 (AP) Y

Y

Table 2
FY 97 Standard NDA and BLA Submissions Approved in FY 97 () and FY 98

Generic Name Sponsor Approval Time (Months) Review
Goal
Met

Total
Time Resubmissions
(if necessary)

AMOXICILLIN/CLARITHROMYCIN/
LANSOPRAZOLE Tap Holdings 4.3 Y

METRONIDAZOLE (TABLET) Searle 5.9 Y

MINOXIDIL Pharmacia And Upjohn 8.5 Y

DILTIAZEM HYDROCHLORIDE Hoechst Marion Rssl 8.5 FDA First Action: 6.0 (AE)
Sponsor Response: 1.9
FDA Second Action: 0.7 (AP) Y

Y

IODIXANOL Nycomed 9.2 Y

DORZOLAMIDE HYDROCHLORIDE/
TIMOLOL MALEATE Merck Res 9.4 Y

CEFDINIR (ORAL SUSPENSION) Parke Davis 11.1 Y

OPRELVEKIN (BLA) Genetics Institute, Inc. 11.1 Y

VALSARTAN/
HYDROCHLOROTHIAZIDE Novartis Pharms 11.2 FDA First Action: 10.7 (AE)
Sponsor Response: 0.2
FDA Second Action: 0.3 (AP) Y

Y

MYCOPHENOLATE MOFETIL
HYDROCHLORIDE Roche Bioscience 11.3 Y

TROVAFLOXACIN MESYLATE Pfizer Cent Res 11.6 Y

ALATROFLOXACIN MESYLATE Pfizer Cent Res 11.6 Y

FEXOFENADINE
HYDROCHLORIDE/
PSEUDOEPHEDRINE
HYDROCHLORIDE Hoechst Marion Rssl 11.7 Y

DESOGESTREL/ETHINYL
ESTRADIOL Organon 11.7 Y

METRONIDAZOLE CREAM Dermik Labs 11.8 Y

TESTOSTERONE Alza 11.8 Y

BECAPLERMIN CONCENTRATE
(BLA, BULK) Chiron Corporation 11.9 Y

RISEDRONATE SODIUM Procter Gamble Pharm 11.8 Y

AMOXICILLIN SKB Pharms 11.9 Y

ESTRADIOL Fournier Res 11.9 Y

GREPAFLOXACIN
HYDROCHLORIDE Glaxo Wellcome 11.9 Y

FOMEPIZOLE Orphan Medcl 11.9 Y

OFLOXACIN Daiichi Pharm 11.9 Y

TERBINAFINE HYDROCHLORIDE Novartis Pharms 12.0 Y

ZOLMITRIPTAN Zeneca 12.0 Y

FINASTERIDE Merck Res 12.0 Y

ACETAMINOPHEN/ASPIRIN/
CAFFEINE Bristol Myers 12.0 Y

CLONAZEPAM Roche 12.0 Y

MICONAZOLE NITRATE Advanced Care Prods 12.0 Y

MONTELUKAST SODIUM
(TABLETS) Merck Res 12.0 Y

MONTELUKAST SODIUM
(CHEWABLE TABLETS) Merck Res 12.0 Y

AMINO ACID Baxter Hlthcare 12.0 Y

RIZATRIPTAN BENZOATE
(TABLETS) Merck 12.0 Y

RIZATRIPTAN BENZOATE
(DISINTEGRATING DISC) Merck 12.0 Y

ETOPOSIDE PHOSPHATE Bristol Myers Squibb 12.0 Y

MUPIROCIN CALCIUM SKB Pharms 12.0 Y

NEDOCROMIL SODIUM Rhone Poulenc Rorer 12.0 Y

MOMETASONE FUROATE
MONOHYDRATE Schering Plough 12.0 Y

TOLTERODINE TARTRATE Pharmacia and Upjohn 12.0 Y

CIPROFLOXACIN
HYDROCHLORIDE/
HYDROCORTISONE Bayer 12.0 Y

TERBINAFINE Novartis Pharms 12.0 Y

ESTRADIOL/NORETHINDRONE
ACETATE Rhone Poulenc Rorer 12.0 Y

PIPERACILLIN SODIUM/
TAZOBACTAM SODIUM Lederle Piperacillin 12.0 Y

BECAPLERMIN (BLA) OMJ Pharmaceuticals, Inc. 12.0 Y

LEVONORGESTREL/ETHINYL
ESTRADIOL Berlex Labs 13.0 Y

LOTEPREDNOL ETABONATE 0.2% Pharmos 13.1 Y

CANDESARTAN CILEXETIL Astra Pharms 13.2 FDA First Action: 11.9 (AE)
Sponsor Response: 0.8
FDA Second Action: 0.4(AP) Y

Y

IBUPROFEN Whitehall Robins 13.6 FDA First Action: 5.8 (AE)
Sponsor Response: 1.8
FDA Second Action: 6.0(AP) Y

Y

BRINZOLAMIDE Alcon 14.1 FDA First Action: 10.2 (AE)
Sponsor Response: 0.4
FDA Second Action: 3.5 (AP) Y

Y

CITALOPRAM HYDROBROMIDE Forest Labs 14.2 FDA First Action: 12.0 (AE)
Sponsor Response: 0.5
FDA Second Action: 1.7 (AP) Y

Y

NARATRIPTAN HYDROCHLORIDE Glaxo Wellcome 14.2 Y

EPROSARTAN MESYLATE SKB Pharms 14.4 FDA First Action: 12.0 (AE)
Sponsor Response: 0.9
FDA Second Action: 1.5 (AP) Y

Y

ALBUMIN HUMAN Molecular Biosystems 14.5 Y²

PARICALCITOL Abbott Labs 15.0 Y

DICLOFENAC SODIUM Alcon 16.3 FDA First Action: 7.2 (NA)
Sponsor Response: 1.4
FDA Second Action: 3.8 (AE)
Sponsor Response: 1.0
FDA Third Action: 1.6 (AE)
Sponsor Response: 0.5
FDA Fourth Action: 0.9 (AP) Y

Y

Y

Y

CHLORHEXIDINE GLUCONATE Perio Prods (ls) 16.8 FDA First Action: 11.2 (AE)
Sponsor Response: 0.7
FDA Second Action: 4.9 (AP) Y

Y

DOXYCYCLINE HYCLATE
(PERIODONTAL DRUG
DELIVERY SYSTEM) Atrix 16.9 FDA First Action: 12.0 (AE)
Sponsor Response: 3.0
FDA Second Action: 1.9 (AP) Y

Y

ROTAVIRUS VACCINE, LIVE,
ORAL, TETRAVALENT (BLA) Wyeth Laboratories, Inc. 19.0 FDA First Action: 14.9 (RL)
Sponsor Response: 1.9
FDA Second Action: 2.2 (AP) Y**

Y

FAMOTIDINE (10 MG) Merck Res 21.2 FDA First Action: 12.0 (AE)
Sponsor Response: 1.6
FDA Second Action: 5.9 (AE)
Sponsor Response: 0.6
FDA Third Action: 1.0 (AP) Y

Y

Y

² Review extension granted due to court ordered hold

Table 3
FY 93 through FY 96 Priority NDA and BLA Submissions Approved in FY 98

Sub-
mission
Year Generic Name Sponsor Approval Time (Months) Review
Goal
Met

Total
Time Resubmissions
(if necessary)

FY 95 TALC Bryan 12.3³ FDA First Action: 11.8 (AE)
Sponsor Response: 8.6
FDA Second Action: 6.0 (AE)
Sponsor Response: 0.7
FDA Third Action: 1.2 (AP) Y

Y

Y

FY 95 DIPHTHERIA & TETANUS
TOXOIDS & ACELLULAR
PERTUSSIS VACCINE
ADSORBED (BLA) North American Vaccine, Inc. 34.0 FDA First Action: 7.2 (NA)
Sponsor Response: 12.7
FDA Second Action: 5.5 (NA)
Sponsor Response: 8.3
FDA Third Action: 0.4 (AP) Y

Y

Y

FY 96 URSODIOL Axcan Pharma (US) 20.5 FDA First Action: 11.9 (AE)
Sponsor Response: 3.2
FDA Second Action: 5.4 (AP) Y

Y

FY 96 EPTIFIBATIDE Cor 25.5 FDA First Action: 11.6 (NA)
Sponsor Response: 6.4
FDA Second Action: 6.0 (AE)
Sponsor Response: 1.4
FDA Third Action: 0.2 (AP) Y

Y

Y

FY 96 DIPHTHERIA TOXOID
CONCENTRATE (BLA, BULK) Statens Serum Institut 34.0 FDA First Action: 9.8 (NA)
Sponsor Response: 2.2
FDA Second Action: 5.6 (NA)
Sponsor Response: 2.0
FDA Third Action: 5.9 (NA)
Sponsor Response: 4.2
FDA Fourth Action: 4.4 (AP) Y

Y

Y

Y

FY 96 TETANUS TOXOID
CONCENTRATE (BLA, BULK) Statens Serum Institut 34.0 FDA First Action: 9.8 (NA)
Sponsor Response: 1.8
FDA Second Action: 5.9 (NA)
Sponsor Response: 2.0
FDA Third Action: 5.9 (NA)
Sponsor Response: 0.5
FDA Fourth Action: 5.8 (RL)
Sponsor Response: 1.9
FDA Fifth Action: 0.4 (AP) Y

Y

Y

Y

Y

³ Adjusted Approval Time - The sponsor had to find a new manufacturer and submit new manufacturing and control data. This time (16.0 months) was excluded from the approval time calculation.

Table 4
FY 93 through FY 96 Standard NDA and BLA Submissions Approved in FY 98

Sub-
mission
Year Generic Name Sponsor Approval Time (Months) Review
Goal
Met

Total
Time Resubmissions
(if necessary)

FY 93 KETOCONAZOLE J And J 57.8 FDA First Action: 38.8 (AE)
Sponsor Response: 8.1
FDA Second Action: 6.0 (AE)
Sponsor Response: 4.2
FDA Third Action: 0.7 (AP) N

Y

Y

FY 93 CIPROFLOXACIN HYDROCHLORIDE Alcon 58.2 FDA First Action: 11.8 (NA)
Sponsor Response: 37.3
FDA Second Action: 6.0 (AE)
Sponsor Response: 2.7
FDA Third Action: 0.5 (AP) Y

Y

Y

FY 93 POOLED PLASMA,
SOLVENT DETERGENT
TREATED (BLA) V. I. Technologies, Inc. 62.2 FDA First Action: 9.6 (NA)
Sponsor Response: 6.8
FDA Second Action: 8.5 (NA)
Sponsor Response: 14.9
FDA Third Action: 6.0 (NA)
Sponsor Response: 3.9
FDA Fourth Action: 6.0 (NA)
Sponsor Response: 5.8
FDA Fifth Action: 0.7 (AP) Y

N

Y

Y

Y

FY 94 TRETINOIN Penederm 33.6 FDA First Action: 12.0 (NA)
Sponsor Response: 9.3
FDA Second Action: 5.7 (NA)
Sponsor Response: 0.6
FDA Third Action: 6.0 (AP) Y

Y

Y^t

FY 95 LOTEPREDNOL ETABONATE 0.5% Pharmos 12.0⁴ FDA First Action: 12.4 (NA)
Sponsor Response: 11.0
FDA Second Action: 5.8 (AE)
Sponsor Response: 3.3
FDA Third Action: 2.9 (AP) N

Y

Y

FY 95 CALFACTANT Ony 21.2 FDA First Action: 11.8 (AE)
Sponsor Response: 3.5
FDA Second Action: 5.9 (AP) Y

Y^t

FY 95 MANGAFODIPIR TRISODIUM Nycomed 26.4 FDA First Action: 11.9 (AE)
Sponsor Response: 1.5
FDA Second Action: 6.0 (AE)
Sponsor Response: 1.1
FDA Third Action: 5.8 (AP) Y

Y

Y

FY 95 SIBUTRAMINE HYDROCHLORIDE Knoll Pharm 27.5 FDA First Action: 15.0 (AE)
Sponsor Response: 6.4
FDA Second Action: 6.0 (AP) Y

Y

FY 95 LIDOCAINE/PRILOCAINE Astra Pharms 30.7 FDA First Action: 12.8 (NA)
Sponsor Response: 4.4
FDA Second Action: 13.5 (AP) N

N

FY 95 FLUTICASONE PROPIONATE Glaxo Wellcome 34.3 FDA First Action: 12.0 (NA)
Sponsor Response: 10.3
FDA Second Action: 5.7 (AE)
Sponsor Response: 0.3
FDA Third Action: 6.0 (AP) Y

Y

Y

FY 96 CISAPRIDE MONOHYDRATE Janssen 14.0 FDA First Action: 12.0 (AE)
Sponsor Response: 1.8
FDA Second Action: 0.2 (AP) Y

Y

FY 96 ALPROSTADIL Pharmacia and Upjohn 15.0 Y

FY 96 CEFDINIR (CAPSULE) Parke Davis 15.0 Y

FY 96 KETORALAC TROMETHAMINE Syntex USA 15.2 FDA First Action: 6.0 (NA)
Sponsor Response: 1.7
FDA Second Action: 6.0 (AE)
Sponsor Response: 0.4
FDA Third Action: 1.1 (AP) Y

Y

Y

FY 96 INTERFERON ALFACON-1 (BLA) Amgen, Inc. 16.7 FDA First Action: 12.0 (AE)
Sponsor Response: 1.1
FDA Second Action: 4.7 (AP) Y

Y

FY 96 VENLAFAXINE
HYDROCHLORIDE Wyeth Ayerst Labs 17.2 FDA First Action: 11.5 (AE)
Sponsor Response: 1.4
FDA Second Action: 4.2 (AP) Y

Y

FY 96 SODIUM CHLORIDE/
POTASSIUM CHLORIDE/
CALCIUM CHLORIDE/
MAGNESIUM CHLORIDE/
SODIUM ACETATE/
SODIUM CITRATE Alcon 18.0 FDA First Action: 6.7 (AE)
Sponsor Response: 4.7
FDA Second Action: 2.7 (AE)
Sponsor Response: 1.1
FDA Third Action: 2.8 (AP) Y

Y

Y

FY 96 RANITIDINE HYDROCHLORIDE Glaxo Wellcome 19.4 FDA First Action: 11.7 (AE)
Sponsor Response: 1.6
FDA Second Action: 6.0 (AP) Y

Y

FY 96 TOLCAPONE Roche 19.8 FDA First Action: 12.0 (AE)
Sponsor Response: 1.8
FDA Second Action: 6.0 (AP) Y

Y

FY 96 EMEDASTINE DIFUMARATE Alcon 21.1 FDA First Action: 10.7 (AE)
Sponsor Response: 8.4
FDA Second Action: 2.1 (AP) Y

Y

FY 96 FAMOTIDINE (20 MG/40 MG) Merck Res 21.8 FDA First Action: 11.9 (NA)
Sponsor Response: 3.9
FDA Second Action: 6.0 (AP) Y

Y

FY 96 FERRIC AMMONIUM
CITRATE Oncomembrane 22.9 FDA First Action: 12.0 (AE)
Sponsor Response: 4.9
FDA Second Action: 6.0 (AP) Y

Y

FY 96 LAMOTRIGINE Glaxo Wellcome 23.2 FDA First Action: 14.5 (AE)
Sponsor Response: 2.7
FDA Second Action: 6.0 (AP) Y**

Y

FY 96 MANGANESE CHLORIDE
TETRAHYDRATE Bracco Dxs 23.9 FDA First Action: 11.9 (AE)
Sponsor Response: 6.3
FDA Second Action: 5.8 (AP) Y

Y

FY 96 DICLOFENAC
SODIUM/MISOPROSTOL Searle 24.0 FDA First Action: 15.0 (NA)
Sponsor Response: 1.4
FDA Second Action: 4.3 (AE)
Sponsor Response: 0.9
FDA Third Action: 2.3 (AP) Y**

Y

Y

FY 96 DOXYCYCLINE HYCLATE
(CAPSULES) Collagenex 25.0 FDA First Action: 11.9 (NA)
Sponsor Response: 7.1
FDA Second Action: 6.0 (AP) Y

Y

FY 96 DAUNORUBICIN HYDROCHLORIDE Bedford Labs 26.4 FDA First Action: 11.8 (AE)
Sponsor Response: 8.5
FDA Second Action: 6.0 (AP) Y

Y

⁴ Adjusted Approval Time - New clinical data supporting a new indication were received 23.4 months after the original receipt date. This new date was used to calculate the total approval time. First action time is based on the original receipt date.

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Generic Name		Sponsor	Approval Time (Months)		Review Goal Met
Generic Name		Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
	NELFINAVIR MESYLATE	Agouron	2.6		Y
	NELFINAVIR MESYLATE (PEDIATRIC)	Agouron	2.6		Y
	LAMIVUDINE/ZIDOVUDINE	Glaxo Wellcome	3.9		Y
	TOBRAMYCIN	Pathogenesis	5.4		Y
	REPAGLINIDE	Novo Nordisk Pharm	5.7		Y
	SAQUINAVIR	Roche	5.9		Y
	SILDENAFIL CITRATE	Pfizer-Agri	5.9		Y
	DACLIZUMAB (BLA)	Hoffmann-La Roche, Inc.	6.0		Y
	PROGESTERONE	Columbia Res Labs	6.0		Y
	RALOXIFENE HYDROCHLORIDE	Lilly	6.0		Y
	CLOPIDOGREL BISULFATE	Sanofi Pharms	6.7	FDA First Action: 6.0 (AE) Sponsor Response: 0.2 FDA Second Action: 0.5 (AP)	Y Y
	RITUXIMAB FORMULATED BULK (BLA)	IDEC Pharmaceuticals Corporation	8.7	FDA First Action: 5.7 (NA) Sponsor Response: 1.6 FDA Second Action: 1.4 (AP)	Y Y
	PACLITAXEL	Baker Norton	8.8		Y ^t
	GLUCAGON HYDROCHLORIDE RECOMBINANT	Novo Nordisk Pharm	8.9		Y
	AMPHOTERICIN B LIPOSOME	Fujisawa USA	8.9		Y
	RITUXIMAB (BLA)	Genentech, Inc.	8.9	FDA First Action: 6.0 (NA) Sponsor Response: 1.0 FDA Second Action: 2.0 (AP)	Y Y
	SACROSIDASE	Orphan Medcl	11.1	FDA First Action: 6.0 (AE) Sponsor Response: 1.3 FDA Second Action: 3.8 (AP)	Y Y
	TECHNETIUM TC 99M APTICIDE	Diatide	12.8	FDA First Action: 6.0 (AE) Sponsor Response: 0.8 FDA Second Action: 6.0 (AP)	Y Y
	LEPIRUDIN	Hoechst Marion Rssl	14.1	FDA First Action: 8.3 (AE) Sponsor Response: 2.5 FDA Second Action: 3.4 (AP)	Y Y
	THALIDOMIDE	Celgene	18.8	FDA First Action: 9.0 (AE) Sponsor Response: 4.3 FDA Second Action: 5.6 (AP)	Y Y

Sub- mission Year	Generic Name	Sponsor	Approval Time (Months)		Review Goal Met
Sub- mission Year	Generic Name	Sponsor	Total Time	Resubmissions (if necessary)	Review Goal Met
FY 95	TALC	Bryan	12.3³	FDA First Action: 11.8 (AE) Sponsor Response: 8.6 FDA Second Action: 6.0 (AE) Sponsor Response: 0.7 FDA Third Action: 1.2 (AP)	Y Y Y
FY 95	DIPHTHERIA & TETANUS TOXOIDS & ACELLULAR PERTUSSIS VACCINE ADSORBED (BLA)	North American Vaccine, Inc.	34.0	FDA First Action: 7.2 (NA) Sponsor Response: 12.7 FDA Second Action: 5.5 (NA) Sponsor Response: 8.3 FDA Third Action: 0.4 (AP)	Y Y Y
FY 96	URSODIOL	Axcan Pharma (US)	20.5	FDA First Action: 11.9 (AE) Sponsor Response: 3.2 FDA Second Action: 5.4 (AP)	Y Y
FY 96	EPTIFIBATIDE	Cor	25.5	FDA First Action: 11.6 (NA) Sponsor Response: 6.4 FDA Second Action: 6.0 (AE) Sponsor Response: 1.4 FDA Third Action: 0.2 (AP)	Y Y Y
FY 96	DIPHTHERIA TOXOID CONCENTRATE (BLA, BULK)	Statens Serum Institut	34.0	FDA First Action: 9.8 (NA) Sponsor Response: 2.2 FDA Second Action: 5.6 (NA) Sponsor Response: 2.0 FDA Third Action: 5.9 (NA) Sponsor Response: 4.2 FDA Fourth Action: 4.4 (AP)	Y Y Y Y
FY 96	TETANUS TOXOID CONCENTRATE (BLA, BULK)	Statens Serum Institut	34.0	FDA First Action: 9.8 (NA) Sponsor Response: 1.8 FDA Second Action: 5.9 (NA) Sponsor Response: 2.0 FDA Third Action: 5.9 (NA) Sponsor Response: 0.5 FDA Fourth Action: 5.8 (RL) Sponsor Response: 1.9 FDA Fifth Action: 0.4 (AP)	Y Y Y Y Y