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APPENDIX B: 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 all PDUFA-related submissions that took place in FY 2004 as well as FY 2003 approvals of FY 2003 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 1997 through FY 2003. 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

Receipt Cohort 1st Review
n 		1st Review
FDA Review		 2nd Review
n		 2nd Review
Sponsor Response 		2nd Review
FDA Review		 Mean Total Approval Time
FY97 23 6.3 10 4.4 3.6 9.5
FY98 31 6.1 12 1.5 2.7 8.3
FY99 27 6.2 9 2.6 2.7 10.0
FY00 25 6.0 10 4.1 4.6 11.5
FY01 12 6.4 10 7.1 4.9 17.0
FY02 13 5.8 6 9.2 5.1 12.4
FY03 15 5.9 3 4.9 6.0 8.1

Approved Standard NDAs/BLAs

Receipt Cohort 1st Review
n 		1st Review
FDA Review 		2nd Review
n 		2nd Review
Sponsor Response 		2nd Review
FDA Review 		Mean Total Approval Time
FY97 89 11.6 42 8.1 4.1 19.5
FY98 5 11.4 41 5.4 4.9 19.3
FY99 74 10.7 37 5.2 4.2 18.1
FY00 76 10.6 45 8.0 4.4 18.9
FY01 53 10.5 35 6.4 4.8 18.5
FY02 63 10.1 31 4.3 3.9 14.5
FY03 42 9.8 12 2.3 2.7 11.3

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 2004 can be found in the appendices of the earlier PDUFA Performance Reports that are available at www.fda.gov/oc/pdufa/.

Terms and Coding Used in Tables

** Major amendment was received within 3 months of the action due date, which extended the review timeframes by 3 months.
Y Yes
N No
Action Codes: AE = Approvable
AP = Approved
NA = Not Approvable
RL = Complete Response
WD = Withdrawn

Table 1 -- FY 2004 Priority NDA and BLA Approvals (by FY of receipt)

Receipt Cohort (FY) Established / Proper Name Applicant Approval Time (Months)- Total Time Approval Ttime (Months) - Resubmissions (if necessary) Review Goal Met
2004 PENTETATE ZINC TRISODIUM HAMEIN PHARMS 3.5   Y
2004 PENTETATE CALCIUM TRISODIUM HAMEINPHARMS 3.5   Y
2004 TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE GILEAD 4.7   Y
2004 AZACITIDINE PHARMION 4.7   Y
2003 PEMETREXED DISODIUM LILLY 4.2   Y
2003 BEVACIZUMAB (BLA) GENETECH, INC. 5.0   Y
2003 CINACALCET HYDROCHLORIDE AMGEN 6.0   Y
2003 CETUXIMAB (BLA) IMCLONE SYSTEMS, INC. 6.0   Y
2003 FERRIC HEXACYANOFERRATE HEYL CHEMISCH 6.7   Y**
2003 HYALURONIDASE ISTA PHARMS 9.0   Y**
2003 OLAZAPINE; FLUOXETINE HYDROCHLORIDE LILLY 13.6 FDA First Action: (AE) 6.0 ;
Sponsor Response: 1.6;
FDA Second Action: (AP) 6.0		 Y first action;
Y second action
2003 APPMORPHINE HYDROCHLORIDE MYLAN BERTEK 15.6 FDA First Action: (AE) 6.0 ;
Sponsor Response: 3.6 ;
FDA Second Action: (AP) 6.0 		Y first action;
Y second action
2003 DESLORATADINE SCHERING 20.9 FDA First Action: (AE) 5.3;
Sponsor Response: 9.6 ;
FDA Second Action: (AP) 6.0 		Y first action;
Y second action
2002 STERILE TALC POWDER BRYAN 14.7 FDA First Action: (AE) 5.9;
Sponsor Response: 3.5 ;
FDA Second Action: (AP) 5.3 		Y first action;
Y second action
2002 ACETYLCYSTEINE CUMBERLAND PHARMS 18.8 FDA First Action: (NA) 6.0 ; Sponsor Response: 6.8 ; FDA Second Action: (AP) 6 Y first action;
Y second action
2002 BOTULISM IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (BLA) CALIFORNIA DEPARTMENT OF HEALTH SERVICES (THE) 22.2 FDA First Action: 6.1 (RL);
Sponsor Response: 10.1;
FDA Second Action: 6.0 (AP) 		Y first action;
Y second action
2002 NITAZOXANIDE ROMARK 25.8 FDA First Action: (AE) 5.8;
Sponsor Response: 14.3;
FDA Second Action: (AP) 5.7 		Y first action;
Y second action
2002 ACAMPROSATE CALCIUM FOREST 31.1 FDA First Action: (NA) 6.0;
Sponsor Response: 19.3;
FDA Second Action: (AP) 5.8 		Y first action;
Y second action
2001 SYNTHETIC HUMAN SECRETIN CHIRHOCLIN 33.9 FDA First Action: (AE) 6.0;
Sponsor Response: 21.9;
FDA Second Action: (AP) 6.0 		Y first action;
Y second action
2001 ABARELIX PRAECIS 35.4 FDA First Action: (NA) 6.0; Sponsor Response: 20.5; FDA Second Action: (AP) 8.9 Y first action;
Y **
second action

Table 2 -- FY 2004 Standard NDA and BLA Approvals (by FY of receipt)

Receipt Cohort (FY) Established / Proper Name Applicant Approval Time (months) - Total Time Approval Time (Months) - Resubmissions (if necessary) Review Goal Met
2004 FLUDEOXYGLUCOSE F-18 WEILL MEDICAL COLLEGE 4.4   Y
2004 AMLEXANOX ACCESS 9.7   Y
2004 ABACAVIR SULFATE; LAMIVUDINE GLAXOSMITHKLINE 9.8   Y
2004 GATIFLOXACIN BRISTOL-MYERS SQUIBB 10.0   Y
2004 ESTRADIOL ACETATE WARNER CHILCOTT 10.0   Y
2004 FAMOTIDINE SCHWARZ 10.0   Y
2004 RANITIDINE HYDROCHLORIDE PFIZER 10.0   Y
2003 CLOBETASOL PROPIONATE GALDERMA LABS 9.0   Y
2003 VORICONAZOLE PFIZER 9.1   Y
2003 MELOXICAM BOEHRINGER INGELHEIM 9.4   Y
2003 GADOTERIDOL BRACCO 9.7   Y
2003 FOLLITROPIN ALFA SERONO 9.9 FDA First Action (NA): 3.9
Sponsor Response: 4.0
FDA Second Action (AP): 2.0 		Y first action;
Y second action
2003 MEMANTINE HYDROCHLORIDE FOREST 9.9   Y
2003 EPINASTINE HYDROCHLORIDE ALLERRGAN 9.9   Y
2003 PEGINTERFERON ALPHA-2A CO-PACKAGED WITH RIBAVIRIN (BLA) HOFFMANN-LA ROCHE INC. 9.9   Y
2003 FOSAMPRENAVIR CALCIUM GLAXOSMITH KLINE 10.0   Y
2003 LEVOFLAXACIN SANTEN 10.0   Y
2003 TINIDAZOLE PRESUTTI LABS 10.0   Y
2003 CETIRIZINE HYDROCHLORIDE PFIZER 10.0   Y
2003 INSULIN GLULISINE AVENTIS 10.0   Y
2003 BACLOFEN SCHWARZ 10.0   Y
2003 SIMVASTATIN; EZETIMIBE MSP SINGAPORE 10.0   Y
2003 MYCOPHENOLIC ACID NOVARTIS 10.0   Y
2003 CEFOTAXIME AND DEXTROSE B BRAUN MEDICAL 10.0   Y
2003 FOLLITROPIN ALFA SERONO 10.0   Y
2003 OMEPRAZOLE SANTARUS 10.0   Y
2003 MORPHINE SULFATE SKYEPHARMA 10.0   Y
2003 L-GLUTAMINE NUTRITIONAL RESTART 10.0   Y
2003 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PFIZER 10.0   Y
2003 MULTIPLE VITAMINS FOR INFUSION SABEX 2002 10.0   Y
2003 MULTIPLE VITAMINS FOR INFUSION MAYNE 10.0   Y
2003 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE WYETH 10.0   Y
2003 EFALIZUMAB (BLA) GENENTECH, INC. 10.0   Y
2003 MULITPLE VITAMINS FOR INFUSION MAYNE 10.9 FDA First Action (AE): 9.5
Sponsor Response: 0.2
FDA Second Action (AP): 1.2 		Y first action;
Y second action
2003 IMMUNE GLOBULIN TRAVENOUS (HUMAN) (BLA) INSTITUTO GRIFOLS, S.A. 11.5   Y**
2003 IBUPROFEN TARO 12.2 FDA First Action (AE): 10.0
Sponsor Response: 0.6
FDA Second Action (AP): 1.6 		Y first action;
Y second action
2003 CLOZAPINE ALAMO 12.3 FDA First Action (AE): 9.6
Sponsor Response: 0.7
FDA Second Action (AP): 2.0 		Y first action;
Y second action
2003 TROSPIUM CHLORIDE INDEVUS 13.0   Y**
2003 VALPROATE SODIUM ANDRX 13.8 FDA First Action (AE): 10.1
Sponsor Response: 1.9
FDA Second Action (TA): 1.8 		Y first action;
Y second action
2003 AMIODARONE HYDROCHLORIDE INTERNATIONAL MEDICATION SYSTEMS 14.9 FDA First Action (AE): 9.9
Sponsor Response: 3.0
FDA Second Action (AP): 2.0 		Y first action;
Y second action
2003 DIGOXIN ROXANE 16.1 FDA First Action (AE): 10.1
Sponsor Response: 5.1
FDA Second Action (AP): 0.9 		Y first action;
Y second action
2003 METFORMIN HYDROCHLORIDE ANDRX 16.3 FDA First Action (AE): 9.9
Sponsor Response: 2.2
FDA Second Action (AE): 2.0 Sponsor Response: 0.2 FDA Third Action (AP): 2.0 		Y first action;
Y second action;
Y third action
2003 FENOFIBRATE CIPHER 16.6 FDA First Action (AE): 9.7
Sponsor Response: 3.5
FDA Second Action (AE): 2.0
Sponsor Response: 0.2
FDA Third Action (TA): 1.2 		Y first action;
Y second action;
Y third action
2003 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE ADAMS 16.7 FDA First Action (AE): 9.8
Sponsor Response: 0.9
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2003 LANSOPRAZOLE TAP 17.1 FDA First Action (AE): 10.0
Sponsor Response: 2.6
FDA Second Action (AP): 4.5 		Y first action;
Y second action
2003 TOBRAMYCIN SULFATE AMERICAN PHARMACEUTICAL PARTNERS 18.6 FDA First Action (AE): 10.0
Sponsor Response: 2.6
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 LANSOPRAZOLE; NAPROXEN TAP 14.2 FDA First Action (AE): 10.0
Sponsor Response: 0.5
FDA Second Action (AP): 3.7 		Y first action;
Y second action
2002 RHO(D) IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (BLA) ZLB BIOPLASMA AG 16.5 FDA First Action: 9.9 (RL)
Sponsor Response: 0.8
FDA Second Action: 5.8 (AP) 		Y first action;
Y second action
2002 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT 19.4 FDA First Action (AE): 10.0
Sponsor Response: 3.4
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 LIDOCAINE HYDROCHLORIDE; EPINEPHRINE VYETERIS 19.4 FDA First Action (AE): 10.0
Sponsor Response: 3.5
FDA Second Action (AP): 5.9 		Y first action;
Y second action
2002 TIMOLOL MALEATE SENJU 20.3 FDA First Action (AE): 9.9
Sponsor Response: 4.8
FDA Second Action (AP): 5.6 		Y first action;
Y second action
2002 SODIUM BICARBONATE; SODIUM CHLORIDE; POLYETHYLENE GLYCOL; BISOCODYL; POTASSIUM CHLORIDE BRAINTREE 20.8 FDA First Action (AE): 10.0
Sponsor Response: 4.8
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 AMLODIPINE MALEATE DR. REDDY'S LABS 22.3 FDA First Action (AE): 10.0
Sponsor Response: 10.4
FDA Second Action (AP): 1.9 		Y first action;
Y second action
2002 LIDOCAINE; PRILOCAINE DENTSPLY 22.9 FDA First Action (AE): 9.9
Sponsor Response: 7.0
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (BLA) OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H 23.0 FDA First Action: 9.9 (RL)
Sponsor Response: 4.5
FDA Second Action: 6.1 (RL)
Sponsor Response: 0.5
FDA Third Action: 2.0 (AP) 		Y first action;
Y second action;
Y third action
2002 LORATADINE PERRIGO 23.8 FDA First Action (AE): 10.0
Sponsor Response: 0.4
FDA Second Action (AE): 2.0
Sponsor Response: 5.4
FDA Third Action (AP): 6.0 		Y first action;
Y second action;
Y third action
2002 NIZATIDINE RELIANT 25.5 FDA First Action (AE): 10.1
Sponsor Response: 9.4
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 SYNTHETIC CONJUGATED ESTROGENS, B DURAMED 25.6 FDA First Action (AE): 13.0
Sponsor Response: 10.6
FDA Second Action (AP): 2.0 		Y** first action;
Y second action
2002 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM 25.6 FDA First Action (AE): 12.2
Sponsor Response: 7.4
FDA Second Action (AP): 6.0 		N first action;
Y second action
2002 FLUTICASONE PROPIONATE GLAXOSMITHKLINE

26.5

FDA First Action (AE): 10.0
Sponsor Response: 10.5
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 RIFAXIMIN SALIX 29.0 FDA First Action (AE): 10.0
Sponsor Response: 13.0
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2002 DULOXETINE HYDROCHLORIDE LILLY 32.7 FDA First Action (AE): 10.0
Sponsor Response: 6.3
FDA Second Action (AE): 6.212
Sponsor Response: 2.8
FDA Third Action (AP): 7.4 		Y first action;
Y second action;
Y third action
2001 RISPERIDONE JANSSEN

25.9

FDA First Action (NA): 9.9
Sponsor Response: 10.0
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2001 SERTACONAZOLE NITRATE JOHNSON & JOHNSON 26.4 FDA First Action (AE): 9.9
Sponsor Response: 14.5
FDA Second Action (AP): 2.0 		Y first action;
Y second action
2001 ESTRADIOL HEMIHYDRATE NOVAVAX 27.4 FDA First Action (WD): 10.0
Sponsor Response: 4.5
FDA Second Action (AP): 12.9 		Y first action;
Y** second action
2001 TADALAFIL LILLY; ICOS 28.8 FDA First Action (AE): 10.0
Sponsor Response: 13.0
FDA Second Action (AP): 5.8 		Y first action;
Y second action
2001 METHYL AMINOLEVULINATE PHOTOCURE, ASA 34.0 FDA First Action (AE): 11.8
Sponsor Response: 9.9
FDA Second Action (AE): 6.0
Sponsor Response: 4.3
FDA Third Action (AP): 2.0 		Y** first action;
Y second action;
Y third action
2001 CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX CELLTECH 38.3 FDA First Action (AE): 10.0
Sponsor Response: 22.3
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2001 DESLORATADINE SCHERING 44.8 FDA First Action (AE): 9.8
Sponsor Response: 29.0
FDA Second Action (AP): 6.0 		Y first action;
Y second action
2000 LEVONORGESTREL; ESTRADIOL BERLEX 40.8 FDA First Action (NA): 11.9
Sponsor Response: 9.4
FDA Second Action (NA): 6.0
Sponsor Response: 11.5
FDA Third Action (AP): 2.0 		Y** first action;
Y second action;
Y third action
2000 OLANZAPINE LILLY 45.4 FDA First Action (AE): 9.4
Sponsor Response: 31.2
FDA Second Action (AP): 4.8 		Y first action;
Y second action
2000 TELITHROMYCIN AVENTIS 49.1 FDA First Action (AE): 15.0
Sponsor Response: 13.8
FDA Second Action (AE): 6.0
Sponsor Response: 8.8
FDA Third Action (AP): 5.5 		Y** first action;
Y second action;
Y third action
2000 FOLLITROPIN BETA ORGANON 49.7 FDA First Action (NA): 10.0
Sponsor Response: 24.7
FDA Second Action (NA): 6.0
Sponsor Response: 6.0
FDA Third Action (AE): 0.0
Sponsor Response: 1.0
FDA Fourth Action (AP): 2.0 		Y first action;
Y second action;
Y third action;
Y fourth action
2000 TECHNETIUM (99m Tc) FANOLESOMAB (BLA) PALATIN TECHNOLOGIES, INC. 55.4 FDA First Action: 10.1 (RL)
Sponsor Response: 36.3
FDA Second Action: 9.0 (AP) 		Y first action;
Y** second action
1999 ESTRADIOL SOLVAY 10.013   Y
1999 HYDROMORPHONE HYDROCHLORIDE PURDUE 68.9 FDA First Action (AE): 12.0
Sponsor Response: 15.1
FDA Second Action (NA): 6.0
Sponsor Response: 5.2
FDA Third Action (AE): 6.0
Sponsor Response: 20.2
FDA Fourth Action (AE): 1.9
Sponsor Response: 0.3
FDA Fifth Action (AP): 2.0 		Y first action;
Y second action;
Y third action;
Y fourth action;
Y fifth action
1997 TRIAMCINOLONE ACETONIDE AVENTIS 87.7 FDA First Action (AE): 12.0
Sponsor Response: 19.5
FDA Second Action (AE): 6.0
Sponsor Response: 22.0
FDA Third Action (AE): 5.9
Sponsor Response: 9.8
FDA Fourth Action (AE): 6.0
Sponsor Response: 0.5
FDA Fifth Action (AP): 6.0 		Y first action;
Y second action;
Y third action;
Y fourth action;
Y fifth action

Table 3 -- FY 2003 Priority NDA and BLA Submissions Approved in FY 2003

Review Type Established / Proper Name Applicant Approval Time (Months) - Total Time Approval time (Months) - Resubmissions (if necessary) Reveiw Goal Met
Priority BORTEZOMIB MILLENNIUM 3.7   Y
Priority IMATINIB MESYLATE NOVARTIS 4.0   Y
Priority RIBAVIRIN SCHERING 5.9   Y
Priority ATAZANAVIR SULFATE BRISTOL-MYERS SQUIBB 6.0   Y
Priority ALPHA-1-PROTEINASE INHIBITOR (HUMAN) (BLA) AVENTIS BEHRING L.L.C. 6.1   Y
Priority DAPTOMYCIN CUBIST 8.7   Y**

Table 4 -- FY 2003 Standard NDA and BLA Submissions Approved in FY 2003

Review Type Established / Proper Name Applicant Approval Time (Months) - Total Time Approval Time (Months) - Resubmission (if necessary) Review Goal Met
Standard MOXIFLOZACIN HYDROCHLORIDE ALCON 6.0   Y
Standard METFORMIN HYDROCLORIDE RANBAXY 9.9   Y
Standard ALENDRONATE SODIUM MERCK 10.0   Y

This report was prepared by FDA's Office of Planning in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). For information on obtaining additional copies contact:

Office of Planning (HFP-10)
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Phone: 301-827-5270|
FAX: 301-827-5260

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