APPENDIX C: LIST OF APPROVED APPLICATIONS

This appendix updates the detailed review histories of the NDAs and PLAs submitted and approved under PDUFA. It shows approvals of FY 93 through FY 96 submissions that took place this year as well as FY 96 approvals of FY 96 submissions. Earlier PDUFA approvals were listed in last year's performance report.

The following two tables summarize the review histories for all approved applications submitted from FY 93 through FY 96. 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 95 and FY 96 submissions will increase in the future as additional applications are approved.

Approved Priority NDAs/PLAs

First Review

Second Review

Total Approval Time

Submission Year

n

FDA Review (months)

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

19

8.6

8

4.8

2.7

12.1

FY96

25

7.7

7

1.3

2.0

8.9

 

Approved Standard NDAs/PLAs

First Review

Second Review

Total Approval Time

Submission Year

n

FDA Review (months)

n

Sponsor Response

FDA Review

FY93

56

14.7

39

4.5

4.6

23.9

FY94

63

12.7

48

5.2

4.2

22.5

FY95

76

12.3

46

2.3

3.8

16.5

FY96

49

11.9

18

1.4

2.9

13.4

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 97 can be found in Appendix B of the "Fourth Annual Performance Report" which is available on the Internet at http://www.fda.gov.

 

TERMS AND CODING USED IN TABLES

†

FY 96 approval of an FY 96 submission. These were not included in earlier PDUFA reports and are included here for completeness.

*

May not appear to add to total due to rounding.

**

Major amendment was received within 3 months of the action due date,
which extended the review timeframes by 3 months.

‡

Tentative Approval

Action code:

NA = Not Approvable

AE = Approvable

AP = Approval

 

Table 1
FY 96 Priority NDA and PLA Submissions Approved in FY 96 (†) and FY 97

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

INDIVAR SULFATE

Merck Research

1.4

Y

†

RITONAVIR ORAL SOLUTION

Abbott Labs

2.3

Y

†

RITONAVIR CAPSULE

Abbott Labs

2.3

Y

†

NEVIRAPINE

Boehringer Pharmeceutical

3.9

Y

†

TOPOTECAN HCL

Smith Kline Beecham

5.2

Y

COAGULATION FACTOR IX (PLA)

Genetics Institute, Inc.

5.4

Y

†

IRINOTECAN HCL

Pharmacia and Upjohn

5.6

Y

†

AZITHROMYCIN DIHYDRATE

Pfizer

5.7

Y

†

STAVUDINE

STAVUDINE

5.9

Y

TROGLITAZONE

Sankyo

6.0

Y

TROGLITAZONE

Parke Davis

6.0

Y

†

ALBENDAZOLE

Smith Kline Beecham

6.0

Y

ATORVASTATIN CALCIUM

Parke Davis

6.0

Y

†

CARMUSTINE

Rhone Poulenc Rorer

7.5

Y

DONEPEZIL HCL

EISAI America

7.7

FDA 1st Action: 5.5 (AE)
Sponsor Response: 0.5
FDA Second Action: 1.7 (AP)

Y

Y

IVERMECTIN

Merck Research

7.7

FDA 1st Action: 6.2 (AE)
Sponsor Response: 0.3
FDA Second Action: 1.2 (AP)

Y

Y

ALPROSTADIL

Vivus

7.8

FDA 1st Action: 6.3 (AE)
Sponsor Response: 1.2
FDA Second Action: 0.4 (AP)

Y

Y

DELAVIRDINE MESYLATE

Pharmacia and Upjohn

8.6

Y

ITRACONAZOLE

Janssen

9.8

Y

†

ELLIOTT B SOLUTION

Orphan Medcl

10.4

Y

BETAINE ANHYDROUS

Orphan Medcl

12.0

Y

ANAGRELIDE HYDROCHLORIDE

Roberts Labs

13.4

FDA 1st Action: 12.0 (AE)
Sponsor Response: 0.2
FDA Second Action: 1.2(AP)

Y

Y

DIPHTHERIA & TETANUS TOXOIDS & ACELLULAR PERTUSSIS VACCINE ADSORBED (PLA)

Smith Kline Beecham Biologicals

14.5

FDA 1st Action: 7.2 (NA)
Sponsor Response: 2.0
FDA Second Action: 5.3 (AP)

Y

Y

DIPHTHERIA & TETANUS TOXOIDS ADSORBED COMBINED BULK (PLA)

Chiron Behring GmbH & Co.

14.5

FDA 1st Action: 7.4 (NA)
Sponsor Response: 2.9
FDA Second Action: 4.1 (AP)

Y

Y

AUTOLOGOUS CULTURED CHONDROCYTES (PLA)

Genzyme Tissue Repair

16.9

FDA 1st Action: 14.8 (AE)
Sponsor Response: 2.0
FDA Second Action: 0.1 (AP)

N

Y

Table 2
FY 96 Standard NDA and PLA Submissions Approved in FY96 (†) and FY 97

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

IMIQUIMOD

3M Pharms

7.1

Y

†

CIDOFOVIR

Gilead

8.7

Y

LORATADINE TABLET

Schering

9.7

Y

IDARUBICIN HCL

Pharmacia and Upjohn

10.2

Y

OLOPATADINE HYDROCHLORIDE

Alcon

10.7

Y

BUPROPION HCL

Glaxo Wellcome (US)

11.3

Y

†

PENCICLOVIR

SKB Pharms

11.3

Y

MIGLITOL

Bayer

11.7

Y

SPARFLOXACIN

Rhone Poulenc Rorer

11.8

Y

AMPHOTERICIN B

Sequus Pharm

11.8

Y

LORATADINE SYRUP

Schering

11.8

Y

AZITHROMYCIN

Pfizer

11.8

Y

VALSARTAN

Novartis Pharms

11.9

Y

HYDROCORTISONE BUTYRATE

Yamanouchi

11.9

Y

CIPROFLOXACIN

Bayer

11.9

Y

CABERGOLINE

Pharmacia and Upjohn

11.9

Y

ESTRADIOL

Theratech

12.0

Y

AMINO ACID w/ ELECTROLYTES IN DEXTROSE w/ CALCIUM

Baxter Healthcare

12.0

Y

AMINO ACIDS/DEXTROSE

Baxter Healthcare

12.0

Y

TAMSULOSIN HCL

Boehringer Pharms

12.0

Y

LEVOFLOXACIN TABS

Johnson RW

12.0

Y

LEVOFLOXACIN INJ

Johnson RW

12.0

Y

ETHINYL ESTRADIOL LEVONORGESTREL

Wyeth Ayerst Labs

12.0

Y

PROGESTERONE GEL

Columbia Res Labs

12.0

Y

LEUPROLIDE ACETATE

TAP Holdings

12.0

Y

NICOTINE INHALATION SYSTEM

Pharmacia and Upjohn

12.0

Y

LETROZOLE

Novartis Pharms

12.0

Y

CERIVASTATIN SODIUM

Bayer

12.0

Y

IRBESARTAN

Sanofi Winthrop

12.1

FDA 1st Action: 12.0 (AE)
Sponsor Response: 0.1
FDA Second Action: 0.0 (AP)

Y

Y

HYDROCHLOROTHIAZIDE/IRBESARTAN

Sanofi Winthrop

12.1

FDA 1st Action: 12.0 (AE)
Sponsor Response: 0.1
FDA Second Action: 0.0 (AP)

Y

Y

 

Table 2, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

TILUDRONATE DISODIUM

Sanofi Winthrop

12.3

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.0(AP)

Y

Y

MOEXIPRIL HCL/HYDROCHLOROTHIAZIDE

Schwarz Pharma (US)

12.8

FDA 1st Action: 10.4(AE)
Sponsor Response: 1.9
FDA 2nd Action: 0.5(AP)

Y

Y

ENALAPRIL MALEATE/FELODIPINE

Astra Merck

12.9

FDA 1st Action: 11.2(AE)
Sponsor Response: 1.2
FDA 2nd Action: 0.5(AP)

Y

Y

QUETIAPINE FUMARATE

Zeneca Pharms

13.9

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 1.7(AP)

Y

Y

GLATIRAMER ACETATE

Teva Pharms

14.3

FDA 1st Action: 11.8(AE)
Sponsor Response: 1.1
FDA 2nd Action: 1.4(AP)

Y

Y

NIACIN

Kos Pharms

14.7

Y

PAROXETINE HCL

SKB Pharms

14.7

FDA 1st Action: 10.7(AE)
Sponsor Response: 2.7
FDA 2nd Action: 1.3(AP)

Y

Y

FENOLDOPAM MESYLATE

Neurex

14.9

Y

SALMETEROL XINAFOATE

Glaxo Wellcome

15.0

Y

MIBEFRADIL DIHYDROCHLORIDE

Roche

15.3

FDA 1st Action: 15.0(AE)
Sponsor Response: 0.3
FDA 2nd Action: 0.0(AP)

Y**

Y

HYDROCODONE BITARTRATE/IBUPROFEN

Knoll Pharm

17.0

FDA 1st Action: 11.7(AE)
Sponsor Response: 1.3
FDA 2nd Action: 3.9(AP)

Y

Y

CARBAMAZEPINE

Shire Labs

17.9

FDA 1st Action: 11.5(AE)
Sponsor Response: 2.0
FDA 2nd Action: 5.4(AP)

Y

Y

PRAMIPEXOLE DIHYDROCHLORIDE

Pharmacia and Upjohn

18.1

FDA 1st Action: 11.9(AE)
Sponsor Response: 0.6
FDA 2nd Action: 5.7(AP)

Y

Y

DOLASETRON MESYLATE

Hoechst Marion Rssl

18.7

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.9
FDA 2nd Action: 5.8(AP)

Y

Y

ALPROSTADIL

Schwarz Pharma (US)

19.1

FDA 1st Action: 12.0(AE)
Sponsor Response: 1.3
FDA 2nd Action: 5.8(AP)

Y

Y

 

Table 2, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

DIAZEPAM

Athena

19.8

FDA 1st Action: 12.0(AE)
Sponsor Response: 3.9
FDA 2nd Action: 3.9(AP)

Y

Y

ROPINIROLE HCL

SKB Pharms

20.6

FDA 1st Action: 12.0(AE)
Sponsor Response: 2.8
FDA 2nd Action: 5.9(AP)

Y

Y

FOLLITROPIN BETA

Organon

20.6

FDA 1st Action: 15.0(NA)
Sponsor Response: 1.2
FDA 2nd Action: 4.5(AP)

Y**

Y

TIAGABINE HCL

Abbott Labs

22.8

FDA 1st Action: 11.8(AE)
Sponsor Response: 5.0
FDA 2nd Action: 6.0(AP)

Y

Y

Table 3
FY 95 Priority NDA and PLA Submissions Approved in FY 97

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

AMLEXANOX

Block Drug

20.0

FDA 1st Action: 11.9 (AE)
Sponsor Response: 3.6
FDA Second Action: 4.4 (AP)

Y

Y

CAPROMAB PENDETIDE (PLA)

Cytogen Corporation

21.5

FDA 1st Action: 6.0 (NA)
Sponsor Response: 6.5
FDA Second Action: 4.5 (NA)
Sponsor Response: 1.9
FDA Third Action: 2.6 (AP)

Y

Y

Y

UREA C-14

Tri Med Speclts

24.5

FDA 1st Action: 12.0 (NA)
Sponsor Response: 3.4
FDA Second Action: 5.8 (AE)
Sponsor Response: 2.3
FDA Third Action: 1.0 (AP)

Y

Y

Y

MYCOPHENOLATE MOFETIL

Syntex USA

31.3

FDA 1st Action: 5.7 (NA)
Sponsor Response: 19.8
FDA Second Action: 5.8 (AP)

Y

Y

Table 4
Standard NDA and PLA Submissions Approved in FY 97

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

CLONIDINE HCL

Fujisawa USA

13.8

Y

IBUPROFEN

Whitehall Robins

14.9

FDA 1st Action: 12.0 (AE)
Sponsor Response: 1.2
FDA Second Action: 1.7 (AP)

Y

Y

RETEPLASE (PLA)

Boehringer Mannheim GmbH

16.0

FDA 1st Action: 11.9 (AE)
Sponsor Response: 0.4
FDA Second Action: 3.6 (AP)

Y

Y

LEVONORGESTREL

Population Council

17.0

FDA 1st Action: 12.0(NA)
Sponsor Response: 3.4
FDA Second Action: 5.8 (AE)
Sponsor Response: 0.4
FDA Third Action: 2.0 (AP)

Y

Y

Y

TRANDOLAPRIL/VERAPAMIL HCL

Knoll Pharm

17.9

FDA 1st Action: 12.0 (AE)
Sponsor Response: 2.1
FDA Second Action: 3.8 (AP)

Y

Y

HAEMOPHILUS B CONJUGATE (MENINGOCOCCAL PROTEIN CONJUGATE) AND HEPATITIS B (RECOMBINANT) VACCINE (PLA)

Merck & Co., Inc.

18.1

FDA 1st Action: 11.2 (NA)
Sponsor Response: 1.6
FDA Second Action: 5.3 (AP)

Y

Y

BUTENAFINE HCL

Penederm

18.5

FDA 1st Action: 12.0 (AE)
Sponsor Response: 1.2
FDA Second Action: 5.3 (AP)

Y

Y

ETODOLAC

Wyeth Ayerst Labs

18.9

FDA 1st Action: 15.1 (AE)
Sponsor Response: 1.1
FDA Second Action: 2.7 (AP)

N

Y

ONDANSETRON HCL

Glaxo Wellcome

19.1

FDA 1st Action: 11.3 (AE)
Sponsor Response: 1.9
FDA Second Action: 6.0 (AP)

Y

Y

PANCRELIPASE

Organon

19.7

FDA 1st Action: 15.0 (AE)
Sponsor Response: 2.4
FDA Second Action: 2.3 (AP)

Y**

Y

CALCIPOTRIENE

Bristol Myers Squibb

20.0

FDA 1st Action: 12.0 (NA)
Sponsor Response: 2.1
FDA Second Action: 5.9 (AP)

Y

Y

CALFACTANT

Ony

21.2

FDA 1st Action: 4.8 (AE)
Sponsor Response: 3.5
FDA Second Action: 5.9 (AP‡)

Y

Y

Table 4, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

VALPROATE SODIUM

Abbott Labs

21.4

FDA 1st Action: 14.6 (AE)
Sponsor Response: 1.3
FDA Second Action: 5.5 (AP)

Y**

Y

PODOFILOX

Oclassen Pharm

21.5

FDA 1st Action: 11.8 (AE)
Sponsor Response: 5.3
FDA Second Action: 4.4 (AP)

Y

Y

SAMARIUM SM153 EDTMP

Cytogen

21.5

FDA 1st Action: 12.0 (NA)
Sponsor Response: 3.6
FDA Second Action: 5.9(AP)

Y

Y

BETAXOLOL HCL/PILOCARPINE HCL

Alcon

22.2

FDA 1st Action: 13.7 (AE)
Sponsor Response: 1.2
FDA Second Action: 3.8 (AE)
Sponsor Response: 2.1
FDA Third Action: 1.4 (AP)

Y**

Y

Y

LOPERAMIDE HCL/SIMETHICONE

McNeil Cons Prods

22.9

FDA 1st Action: 11.8 (AE)
Sponsor Response: 5.3
FDA Second Action: 5.9 (AP)

Y

Y

DILTIAZEM MALATE

Merck

23.1

FDA 1st Action: 12.0 (AE)
Sponsor Response: 10.2
FDA Second Action: 0.9 (AP)

Y

Y

DILTIAZEM MALATE/ENALAPRIL MALEATE

Merck

23.1

FDA 1st Action: 12.0 (AE)
Sponsor Response: 10.2
FDA Second Action: 0.9 (AP)

Y

Y

DOLASETRON MESYTLATE

Hoechst Marion Rssl

23.4

FDA 1st Action: 17.2 (AE)
Sponsor Response: 0.9
FDA Second Action: 5.4 (AP)

N

Y

DANAPAROID SODIUM

Organon

23.8

FDA 1st Action: 12.7 (NA)
Sponsor Response: 0.2
FDA Second Action: 6.0 (AE)
Sponsor Response: 3.9
FDA Third Action: 1.2 (AP)

Y**

Y

Y

TOPIRAMATE

Johnson RW

23.8

FDA 1st Action: 12.0 (AE)
Sponsor Response: 6.0
FDA Second Action: 5.9 (AP)

Y

Y

TAZAROTENE

Allergan

23.8

FDA 1st Action: 11.6 (NA)
Sponsor Response: 0.9
FDA Second Action: 5.9 (AE)
Sponsor Response: 0.7
FDA Third Action: 4.7 (AP)

Y**

Y

Y

Table 4, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

SUMATRIPTAN

Glaxo Wellcome

 

23.9

FDA 1st Action: 12.0 (NA)
Sponsor Response: 2.1
FDA Second Action: 5.8 (AE)
Sponsor Response: 0.5
FDA Third Action: 3.6 (AP)

Y

Y

Y

TRETINOIN GEL

Adv Polymer

24.1

FDA 1st Action: 15.0 (NA)
Sponsor Response: 3.1
FDA Second Action: 6.0 (AP)

Y**

Y

BUDESONIDE

Astra USA

24.5

FDA 1st Action: 12.0 (AE)
Sponsor Response: 2.9
FDA Second Action: 3.5 (AE)
Sponsor Response: 0.3
FDA Third Action: 5.8 (AP)

Y

Y

Y

HYDROCHLOROTHIAZIDE

Watson Labs

25.6

FDA 1st Action: 9.2 (NA)
Sponsor Response: 8.9
FDA Second Action: 4.7 (AE)
Sponsor Response: 1.8
FDA Third Action: 1.0 (AP)

Y

Y

Y

TOREMIFENE CITRATE

Orion

28.8

FDA 1st Action: 12.0 (AE)
Sponsor Response: 4.0
FDA Second Action: 6.0 (AE)
Sponsor Response: 2.8
FDA Third Action: 4.1 (AP)

Y

Y

Y

BROMFENAC SODIUM

Wyeth Ayerst Labs

30.5

FDA 1st Action: 11.9 (AE)
Sponsor Response: 1.6
FDA Second Action: 7.5 (AE)
Sponsor Response: 4.9
FDA Third Action: 4.6 (AP)

Y

N

Y

Table 5
FY 94 Standard NDA and PLA Submissions Approved in FY 97

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

FOSFOMYCIN TROMETHAMINE

Zambon

26.7

FDA 1st Action: 11.7 (NA)
Sponsor Response: 9.3
FDA Second Action: 5.7 (AP)

Y

Y

ZILEUTON

Abbott Labs

28.7

FDA 1st Action: 15.0 (NA)
Sponsor Response: 7.7
FDA Second Action: 6.0 (AP)

Y**

Y

BRIMONIDINE TARTRATE

Allergan

29.4

FDA 1st Action: 11.8 (NA)
Sponsor Response: 14.4
FDA Second Action: 3.2 (A.P)

Y

Y

ESTRADIOL

Parke Davis

3.04

FDA 1st Action: 12.0 (NA)
Sponsor Response: 2.6
FDA Second Action: 1.5 (NA)
Sponsor Response: 8.2
FDA Third Action: 6.0 (AP)

Y

Y

Y

BECLOMETHASONE DIPROPIONATE

Schering

30.8

FDA 1st Action: 11.9 (AE)
Sponsor Response: 3.2
FDA Second Action: 6.0 (AE)
Sponsor Response: 4.0
FDA Third Action: 5.7(AP)

Y

Y

Y

BUPROPION HYDROCHLORIDE

Glaxo Wellcome

31.2

FDA 1st Action: 14.8 (NA)
Sponsor Response: 4.0
FDA Second Action: 5.6 (AE)
Sponsor Response: 2.1
FDA Third Action: 4.7 (AP)

Y**

Y

Y

ZINC ACETATE

Lemmon

31.2

FDA 1st Action: 14.0 (AE)
Sponsor Response: 13.8
FDA Second Action: 3.4 (AP)

Y**

Y

TRETINOIN CREAM

Penederm

33.6

FDA 1st Action: 12.0 (NA)
Sponsor Response: 8.9
FDA Second Action: 6.0 (NA)
Sponsor Response: 0.6
FDA Third Action: 6.0 (AP)

Y

Y

Y

TRETINOIN GEL

Penederm

33.6

FDA 1st 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

CICLOPIROX

Hoechst Marion Rssl

33.8

FDA 1st Action: 12.0 (AE)
Sponsor Response: 3.2
FDA Second Action: 6.0 (AE)
Sponsor Response: 6.7
FDA Third Action: 5.9 (AP)

Y

Y

Y

Table 5, continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

TIZANIDINE HCL

Athena Neurosciences

35.7

FDA 1st Action: 15.0 (NA)
Sponsor Response: 6.2
FDA Second Action: 6.0 (AE)
Sponsor Response: 6.5
FDA Third Action: 2.1 (AP)

Y

Y

HYDROCORTISONE BUTEPRATE

Savage Labs

35.7

FDA 1st Action: 7.8 (NA)
Sponsor Response: 14.3
FDA Second Action: 6.0 (AE)
Sponsor Response: 2.9
FDA Third Action: 4.7 (AP)

Y**

Y

FERUMOXSIL

Advanced Magnetics

36.5

FDA 1st Action: 29.5 (AE)
Sponsor Response: 1.7
FDA Second Action: 5.3 (AP)

Y

Y

LOPERAMIDE HCL

McNeil Cons Prods

40.3

FDA 1st Action: 12.0 (AE)
Sponsor Response: 9.2
FDA Second Action: 5.8 (AE)
Sponsor Response: 7.5
FDA Third Action: 5.9 (AP)

Y

Y

Y

SERMORELIN ACETATE

Serono Labs

41.9

FDA 1st Action: 11.9 (NA)
Sponsor Response: 25.0
FDA Second Action: 5.0 (AP)

Y

Y

Y

ARBUTAMINE HCL

Gensia

44.2

FDA 1st Action: 15.0 (NA)
Sponsor Response: 6.7
FDA Second Action: 6.0 (NA)
Sponsor Response: 6.6
FDA Third Action: 6.0 (AE)
Sponsor Response: 2.2
FDA Fourth Action: 1.9 (AP)

Y**

Y

Y

TRICLOSAN/SODIUM FLUORIDE

Colgate Palmolive

44.5

FDA 1st Action: 15.0 (NA)
Sponsor Response: 6.1
FDA Second Action: 6.0 (AE)
Sponsor Response: 1.2
FDA Third Action: 6.0 (AE)
Sponsor Response: 4.3
FDA Fourth Action: 5.9 (AP)

Y**

Y

Table 6
FY 93 Standard NDA and PLA Submissions Approved in FY 97

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

ALBUTEROL SULFATE/ IPRATROPIUM BROMIDE

Boehringer Ingelheim

41.0

FDA 1st Action: 9.1 (NA)
Sponsor Response: 5.0
FDA Second Action: 4.8 (NA)
Sponsor Response: 5.0
FDA Third Action: 6.0 (AE)
Sponsor Response: 5.1
FDA Fourth Action: 6.0 (AP)

Y

Y

Y

Y

ACITRETIN

Roche

45.0

FDA 1st Action: 15.0 (NA)
Sponsor Response: 5.1
FDA Second Action: 6.0 (AE)
Sponsor Response: 2.9
FDA Third Action: 6.0 (AE)
Sponsor Response: 4.0
FDA Fourth Action: 6.0 (AP)

Y

Y

Y

Y

DIGOXIN

Glaxo Wellcome

48.0

FDA 1st Action: 12.8 (AE)
Sponsor Response: 13.3
FDA Second Action: 2.4 (AE)
Sponsor Response: 13.8
FDA Third Action: 1.8 (AE)
Sponsor Response: 3.5
FDA Fourth Action: 0.4 (AP)

Y**

Y

Y

Y

FOLLITROPIN ALPHA

Serono Labs

48.5

FDA 1st Action: 11.9 (NA)
Sponsor Response: 28.1
FDA Second Action: 6.0 (AE)
Sponsor Response: 0.1
FDA Third Action: 2.4 (AP)

Y

Y

Y

ARDEPARIN SODIUM

Wyeth Ayerst Labs

53.2

FDA 1st Action: 11.3 (NA)
Sponsor Response: 2.2
FDA Second Action: 4.6 (NA)
Sponsor Response: 2.8
FDA Third Action: 8.9 (NA)
Sponsor Response: 2.5
FDA Fourth Action: 4.7 (NA)
Sponsor Response: 3.9
FDA Fifth Action: 5.7 (AE)
Sponsor Response: 5.6
FDA Sixth Action: 0.7 (AP)

Y

Y

N

Y

Y

Y