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 99 as well as FY 98 approvals of FY 98 submissions. Earlier PDUFA approvals were listed in previous performance reports (http://www.fda.gov/oc/pdufa/reports.html).

The following two tables summarize the review histories for all approved applications submitted from FY 93 through FY 98. 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
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
31
7.5
13
3.1
3.7
12.1
FY97
23
6.3
10
4.4
3.6
9.5
FY98
29
6.1
11
1.3
2.4
7.5
Approved Standard NDAs/BLAs
 
1st Review
2nd Review
Total Approval Time
Receipt Cohort
n
FDA Review
n
Sponsor Response
FDA Review
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
70
11.9
37
3.4
4.0
16.0
FY97
74
11.5
27
2.4
3.1
13.6
FY98
31
11.3
7
2.1
3.8
12.7

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 at http://www.fda.gov/opacom/7pdufa.html.

TERMS AND CODING USED IN TABLES

check  FY 98 approval of an FY 98 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WD = Withdrawn 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 1998 Priority NDA and BLA Submissions Approved in FY 98 (check ) and FY 99
 
Generic Name
Sponsor
Approval Time (Months)
Review Goal Met
Total Time
Resubmissions
(if necessary)
           
check
 EFAVIRENZ  Dupont Pharms 
3.2
  
Y
check
 FOMIVIRSEN SODIUM  Ciba Vision  
4.6
  
Y
check
 TRASTUZUMAB (BLA)  Genentech, Inc. 
4.7
  
Y
check
 NEVIRAPINE  Boehringer Pharms 
4.7
  
Y
  ETANERCEPT (BLA)  Immunex Corporation 
5.8
  
Y
  ABACAVIR SULFATE (TABLET)  Glaxo Wellcome 
5.8
  
Y
  ABACAVIR SULFATE (ORAL SOLUTION)  Glaxo Wellcome 
5.8
  
Y
  OCTREOTIDE ACETATE  Novartis Pharms 
5.9
  
Y
check
 RIBAVIRIN  Schering Plough Res 
5.9
  
Y
check
 BASILIXIMAB (BLA)  Novartis Pharmaceutical Corporation 
6.0
  
Y
check
 PALIVIZUMAB (BLA)  MedImmune, Inc 
6.0
  
Y
check
 CAPECITABINE  HLR 
6.0
  
Y
check
 RIFAPENTINE  Hoechst Marion Rssl 
6.0
  
Y
check
 LEFLUNOMIDE  Hoechst Marion Rssl 
6.0
  
Y
  BUSULFAN  Orphan Medcl 
6.0
  
Y
  CELECOXIB   Searle 
6.0
  
Y
check
 TIROFIBAN HYDROCHLORIDE .05MG/ML   Merck Res 
6.4
 FDA First Action: 6.0 (AE) 
Y
      Sponsor Response: 0.2   
      FDA Second Action: 0.3 (AP) 
Y
check
 TIROFIBAN HYDROCHLORIDE .25MG/ML   Merck Res 
6.4
 FDA First Action: 6.0 (AE) 
Y
      Sponsor Response: 0.2   
      FDA Second Action: 0.3 (AP) 
Y
  HEPATITIS B IMMUNE GLOBULIN (HUMAN) (PLA)  Nabi 
7.3
 FDA First Action: 5.6 (RL) 
Y
    Sponsor Response: 0.2   
      FDA Second Action: 1.5 (AP) 
Y
check
 INFLIXIMAB (BLA)  Centocor, Inc. 
7.8
 FDA First Action: 6.0 (RL) 
Y
      Sponsor Response: 1.2   
      FDA Second Action: 0.6 (AP) 
Y
  MIDAZOLAM HYDROCHLORIDE  Roche 
8.2
 FDA First Action: 5.9 (AE) 
Y
      Sponsor Response: 2.0   
      FDA Second Action: 0.3 (AP)
 
 

  

Y
  ALITRETINOIN  Ligand 
8.3 
 FDA First Action: 6.0 (AE) 
Y
      Sponsor Response: 0.3   
      FDA Second Action: 2.0 (AP) 
Y
check
 VALRUBICIN   Anthra 
8.8
  
Y**
check
 GLUCAGON   Lilly 
9.0
  
Y**
check
 LEVONORGESTREL/ ETHINYL ESTRADIOL   Gynetics 
9.0
  
Y**
  THYROTROPIN ALFA   Genzyme Fine 
11.5
 FDA First Action: 9.0 (AE) 
Y**
      Sponsor Response: 0.8   
      FDA Second Action: 1.7 (AP) 
Y
  TEMOZOLOMIDE  Schering 
11.9
 FDA First Action: 6.0 (AE) 
Y
      Sponsor Response: 4.4   
      FDA Second Action: 1.5 (AP) 
Y
 
 TECHNETIUM TC 99M DEPREOTIDE  Diatide 
13.6
 FDA First Action: 6.0 (AE) 
Y
    Sponsor Response: 1.8   
      FDA Second Action: 5.8 (AP) 
Y
 
 FERRIC SODIUM GLUCONATE   R and D Labs 
13.6
 FDA First Action: 6.0 (AE) 
Y
    Sponsor Response: 1.7   
      FDA Second Action: 6.0 (AP) 
Y
  DENILEUKIN DIFTITOX (BLA)  Seragen, Inc. 
13.9
 FDA First Action: 6.0 (RL) 
Y
      Sponsor Response: 1.9   
      FDA Second Action: 5.9 (AP) 
Y

Table 2
FY 1998 Standard NDA and BLA Submissions Approved in FY 98 (check ) and FY 99
 
Generic Name
Sponsor
Approval Time (Months)
Review Goal Met
Total Time
Resubmissions

(if necessary)
           
check  IOVERSOL  Mallinckrodt Medcl 
7.9
  
Y
  PAROXETINE HYDROCHLORIDE (CAPSULE)  SKB Pharms 
9.5
  
Y
  ESTRADIOL  Novo Nordisk  
9.7
  
Y
  OXYCODONE HYDROCHLORIDE  Roxane 
9.9
  
Y
  VERAPAMIL HYDROCHLORIDE  Elan Pharm 
10.9
  
Y
  ITRACONAZOLE  Janssen 
11.1
  
Y
  FLUOXETINE HYDROCHLORIDE   Lilly 
11.6
  
Y
  METRONIDAZOLE  Galderma 
11.7
  
Y
  SYNTHETIC CONJUGATED ESTROGENS  Duramed Pharms 
11.8
  
Y
  SEVELAMER HYDROCHLORIDE  Geltex 
11.9
  
Y
  IBUPROFEN  Whitehall Robins 
11.9
  
Y
  HUMAN INSULIN   Novo Nordisk  
11.9
  
Y
  OXYBUTYNIN CHLORIDE  Alza 
11.9
  
Y
  CERNEVIT-12 MULTIVITAMINS   Baxter Hlthcare 
11.9
  
Y
  TROVAFLOXACIN MESYLATE / AZITHROMYCIN ***  Pfizer 
12.0
  
Y
  ESTRADIOL /NORETHINDRONATE ACETATE   Novo Nordisk 
12.0
  
Y
  AMOXICILLIN (TABLET)  SKB Pharms 
12.0
  
Y
  AMOXICILLIN (POWDER)  SKB Pharms 
12.0
  
Y
  CLOTRIMAZOLE  Schering Plough  
12.01
  
Y
  MICONAZOLE NITRATE  Advanced Care Prods 
12.0
  
Y
  METHOXSALEN  Therakos 
12.0
  
Y
  CALCITRIOL  Roche 
12.0
  
Y
  MYCOPHENOLATE MOFETIL  Roche  
12.0
  
Y
  RAPACURONIUM BROMIDE  Organon 
13.8
 FDA First Action: 9.9 (AE) 
Y
      Sponsor Response: 1.9   
      FDA Second Action: 2.0 (AP) 
Y
  PAROXETINE HYDROCHLORIDE (TABLET)  SKB Pharms 
13.9
 FDA First Action: 9.7 (AE) 
Y
        Sponsor Response: 2.4   
        FDA Second Action: 1.9 (AP) 
Y
  DOXERCALCIFEROL  Bone Care 
15.0
  
Y **
  LEVOBUPIVACAINE  Darwin Discovery 
15.3
 FDA First Action: 10.0 (AE) 
Y
        Sponsor Response: 3.4   
        FDA Second Action: 1.9 (AP) 
Y
  RABEPRAZOLE SODIUM  Eisai (US) 
16.6
 FDA First Action: 10.0 (AE) 
Y
        Sponsor Response: 1.2   
        FDA Second Action: 5.5 (AP) 
Y
  CIMETIDINE  SKB Pharms 
18.3
 FDA First Action: 11.6(AE) 
Y
        Sponsor Response: 0.8   
        FDA Second Action: 5.9 (AP) 
Y
  RITONAVIR  Abbott Labs 
19.1
 FDA First Action: 12.0(NA) 
Y
        Sponsor Response: 3.3   
        FDA Second Action: 3.9 (AP) 
Y
  ZALEPLON  Wyeth Ayerst Labs 
19.2
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 1.8   
        FDA Second Action: 5.4 (AP) 
Y

1 This application was withdrawn on 29-Jan-96 because of insufficient data (new patients had to be enrolled and new data submitted). It was resubmitted on 25-Nov-97. This date was used to calculate all times. The original receipt date was 27-Apr-95.

*** This application was submitted on 19-Dec-1997, approved 18-Dec-1998, and then withdrawn on 22-Sep-99.

Table 3
FY 1997 Priority NDA and BLA Submissions Approved in FY 99
 
Generic Name
Sponsor
Approval Time (Months)
Review Goal Met
Total Time
Resubmissions

(if necessary)
           
  DALFOPRISTIN/QUINUPRISTIN  Rhone Poulenc Rorer 
7.82
 FDA First Action: 6.0 (AE) 
Y
         Sponsor Response: 16.7   
      FDA Second Action: 1.9 (AP) 
Y
         
  CAFFEINE CITRATE   Opr Develop LP 
24.9
 FDA First Action: 6.0 (AE) 
Y
        Sponsor Response: 13.0   
        FDA Second Action: 6.0 (AP) 
Y
  ORLISTAT  Roche 
28.8
 FDA First Action: 9.0 (WD) 
Y **
      Sponsor Response: 2.7   
      FDA Second Action: 5.8 (AE) 
Y
      Sponsor Response: 8.3   
      FDA Third Action: 3.1 (AP) 
Y

2 The total approval time was adjusted because of a negative plant inspection. The time period until an acceptable inspection was received (05-Mar-98 to 26-Jul-99) was excluded from this time.

Table 4
FY 1997 Standard NDA and BLA Submissions Approved in FY 99
 
Generic Name
Sponsor
Approval Time (Months)
Review Goal Met
Total Time
Resubmissions

(if necessary)
           
  TELMISARTAN   Boehringer Ingelheim 
13.5
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 1.3   
        FDA Second Action: 0.2 (AP) 
Y
  DALFOPRISTIN/QUINUPRISTIN  Rhone Poulenc Rorer 
13.83
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 10.7   
        FDA Second Action: 1.9 (AP) 
Y
  TOPIRAMATE  RW Johnson  
14.8
 FDA First Action: 11.6 (AE) 
Y
        Sponsor Response: 1.2   
        FDA Second Action: 2.0 (AP) 
Y
  LYME DISEASE VACCINE (Recombinant OspA) (PLA)  SmithKline Beecham Biologicals 
15.2
 FDA First Action: 10.5 (RL) 
Y
  Sponsor Response: 1.4   
      FDA Second Action: 3.2 (AP) 
Y
  GABAPENTIN   Parke Davis 
15.3
 FDA First Action: 12.0 (NA) 
Y
        Sponsor Response: 1.4   
        FDA Second Action: 1.9 (AP) 
Y
  CILOSTAZOL   Otsuka Pharm 
15.9
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 1.9   
        FDA Second Action: 2.0 (AP) 
Y
  13 C-UREA  Alimenterics 
17.3
 FDA First Action: 12.0 (NA) 
Y
        Sponsor Response: 3.6   
        FDA Second Action: 1.7 (AP) 
Y
  INTERFERON ALFA-N1 (LYMPHOBLASTOID) (PLA)  Wellcome Foundation Limited, Wellcome Research Laboratories 
17.8
 FDA First Action: 11.9 (RL) 
Y
    Sponsor Response: 2.0   
    FDA Second Action: 2.0 (RL) 
Y
        Sponsor Response: 0.4   
        FDA Third Action: 1.5 (AP) 
Y
  ONDANSETRON  Glaxo Wellcome 
18.9
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 0.9   
        FDA Second Action: 6.0 (AP) 
Y
  LEVALBUTEROL HYDROCHLORIDE   Sepracor 
20.8
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 2.8   
        FDA Second Action: 6.0 (AP) 
Y
  PROGESTERONE  Schering Plough 
21.2
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 5.6   
        FDA Second Action: 3.6 (AP) 
Y
  FAMOTIDINE  Merck Res 
22.2
 FDA First Action: 12.0 (AE) 
Y
        Sponsor Response: 2.7   
        FDA Second Action: 6.0 (AE) 
Y
        Sponsor Response: 0.4   
        FDA Third Action: 1.1 (AP) 
Y
  ANTI-THYMOCYTE GLOBULIN (RABBIT) (PLA)  Pasteur Merieux Serums et Vaccins, S.A. 
23.4
 FDA First Action: 12.0 (RL) 
Y
    Sponsor Response: 1.3   
        FDA Second Action: 4.7 (RL) 
Y
        Sponsor Response: 0.6   
        FDA Third Action: 4.8 (AP) 
Y
  FENTANYL CITRATE  Anesta 
23.7
 FDA First Action: 12.0 (NA) 
Y
        Sponsor Response: 5.7   
        FDA Second Action: 6.0 (AP) 
Y
  MODAFINIL  Cephalon 
23.8
 FDA First Action: 12.0 (AE) 
Y
      Sponsor Response: 6.0   
      FDA Second Action: 5.8 (AP) 
Y

3 The total approval time was adjusted because of a negative plant inspection. The time period until an acceptable inspection was received (04-Sep-98 to 26-Jul-99) was excluded from this time.

Table 5
FY 1996 Priority NDA and BLA Submissions Approved in FY 99
 
Generic Name
Sponsor
Approval Time (Months)
Review Goal Met
Total Time
Resubmissions

(if necessary)
           
  COAGULATION FACTOR VIIa (Recombinant) (BLA)  Novo Nordisk A/S 
34.5
 FDA First Action: 11.6 (NA) 
Y
    Sponsor Response: 5.3   
      FDA Second Action: 5.4 (RL) 
Y
      Sponsor Response: 1.0   
      FDA Third Action: 6.0 (RL) 
Y
      Sponsor Response: 2.8   
      FDA Fourth Action: 2.4 (AP) 
Y


Table 6
FY 1996 Standard NDA and BLA Submissions Approved in FY 99
 
Generic Name
Sponsor
Approval Time (Months)
Review Goal Met
Total Time
Resubmissions

(if necessary)
           
  SIMETHICONE- CELLULOSE   Bracco DXS 
25.0
 FDA First Action: 12.0 (NA) 
Y
    Sponsor Response: 7.0   
    FDA Second Action: 6.0 (AP) 
Y
  ANTIHEMOPHILIC FACTOR / VON WILLEBRAND FACTOR COMPLEX (HUMAN) (BLA)  Centeon Pharma GmbH 
30.5
 FDA First Action: 15.0 (NA) 
Y
    Sponsor Response: 4.2   
    FDA Second Action: 5.8 (RL) 
Y
        Sponsor Response: 5.1   
        FDA Third Action: 0.5 (AP) 
Y
  LIDOCAINE   Teikoku Pharma USA 
33.2
 FDA First Action: 10.2 (NA) 
Y
        Sponsor Response: 13.5   
        FDA Second Action: 6.0 (AE) 
Y
        Sponsor Response: 1.6   
        FDA Third Action: 1.9 (AP) 
Y
  POLYETHYLENE GLYCOL 3350   Braintree Labs 
35.7
 FDA First Action: 11.9 (NA) 
Y
        Sponsor Response: 15.3   
        FDA Second Action: 6.0 (AE) 
Y
        Sponsor Response: 0.5   
        FDA Third Action: 2.0 (AP) 
Y

 
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