APPENDIX B: APPROVAL HISTORY OF FY 93, FY 94, AND FY 95 SUBMISSIONS

 

This appendix presents the NDA and PLA approvals for the FY 93, FY 94, and FY 95 submissions. Approvals are listed in order of total approval time, by submission year and priority designation:

Table 1: FY 93 priority submissions
Table 2: FY 93 standard submissions
Table 3: FY 94 priority submissions
Table 4: FY 94 standard submissions
Table 5: FY 95 priority submissions
Table 6: FY 95 standard submissions

The following tables show summary statistics detailing the average review, response, and approval times for those applications. Times are in months. Not all applications require a second review. The mean total approval times for the FY 94 and FY 95 submissions should 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

15

8.5

4

1.3

0.3

9.0

 

Approved Standard NDAs/PLAs

First Review

Second Review

Total Approval Time

Submission Year

n

FDA Review (months)

n

Sponsor Response

FDA Review

FY93

51

14.8

34

3.6

4.5

21.7

FY94

47

12.3

32

3.5

3.8

18.4

FY95

48

12.1

19

1.1

2.6

13.6

 

 

TERMS AND CODING USED IN TABLES

 

†

FY 96 approvals

*

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.

Action code:

NA = Not Approvable

AE = Approvable

AP = Approval

 

 

Table 1
Priority NDA and PLA Approvals—FY 93 Submissions
(Approvals from September 1, 1992—September 30, 1996)

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

LEVOMETHADYL ACETATE HCL

Biodevelopment

0.6

Y

FENTANYL CITRATE

Anesta

4.3

Y

TACROLIMUS INJECTABLE

Fujisawa USA

8.1

Y

TACROLIMUS CAPSULES

Fujisawa USA

8.4

Y

DORNASE ALFA (PLA)

Genentech, INC.

9.0

Y

IMIGLUCERASE

Genzyme

12.1

N

APROTININ

Miles Pharmaceutical

13.2

FDA 1st Action: 7.2(AE)
Sponsor Response: 5.5
FDA 2nd Action: 0.5(AP)

Y

Y

METFORMIN HYDROCHLORIDE

Bristol Myers Squibb

15.0

Y**

VINORELBINE TARTRATE

Burroughs Wellcome

15.9

FDA 1st Action: 14.9(AE)
Sponsor Response: 0.3
FDA 2nd Action: 0.7(AP)

Y**

Y

FLUDEOXYFLUCOSE F-18

Downstate Clinical

19.0

N

MILRINONE LACTATE

Sterling Winthrop

19.3

FDA 1st Action: 3.6(NA)
Sponsor Response: 7.1
FDA 2nd Action: 1.2(AE)
Sponsor Response: 1.8
FDA 3rd Action: 5.5(AP)

Y

Y

Y

RHO(D) IMMUNE GLOBULIN
INTRAVENOUS (HUMAN)(PLA)

Rh Pharmaceuticals Inc.

21.7

FDA 1st Action: 13.8(NA)
Sponsor Response: 1.1
FDA 2nd Action: 6.8(AP)

N

N

†

DAUNORUBICIN CITRATE

Nexstar

37.5

FDA 1st Action: 11.2(NA)
Sponsor Response: 11.4
FDA 2nd Action: 6.0(AE)
Sponsor Response: 3.0
FDA 3rd Action: 6.0(AP)

Y

Y

Y

 

Table 2
Standard NDA and PLA Approvals—FY 93 Submissions
(Approvals from September 1, 1992—September 30, 1996)

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

DESOGESTREL/ETHINYL ESTRADIOL

Johnson RW

2.2

Y

SOMATROPIN, BIOSYNTHETIC

Genetech, Inc.

4.2

Y

DOBUTAMINE HYDROCHLORIDE

Baxter Healthcare

6.9

FDA 1st Action: 3.2(NA)
Sponsor Response: 3.1
FDA 2nd Action: 0.6(AP)

Y

Y

ROCURONIU, BROMIDE

Organon

8.6

FDA 1st Action: 6.4(AE)
Sponsor Response: 1.0
FDA 2nd Action: 1.2(AP)

Y

Y

TRIMETREXATE

U.S. Bioscience

10.5

Y

CLOTRIMAZOLE

Miles Pharmaceutical

10.4

FDA 1st Action: 7.3(AE)
Sponsor Response: 0.6
FDA 2nd Action: 2.4(AP)

Y

Y

TIMOLOL MALEATE

Merck

10.9

FDA 1st Action: 6.5(AE)
Sponsor Response: 1.1
FDA 2nd Action: 3.3(AP)

Y

Y

DESMOPRESSIN ACETATE

Rhone Poulenc Rorer

11.5

Y

FAMCICLOVIR

SmithKline Beecham

12.0

Y

ISONIAZID/PYRAZINAMIDE/RIFAMPIN

Marion Merrell

12.4

N

NAPROXEN SODIUM

Hamilton

12.8

N

BUDESONIDE

Astra

13.5

FDA 1st Action: 11.5(AE)
Sponsor Response: 0.4
FDA 2nd Action: 1.5(AP)

Y

Y

CLARITHROMYCIN

Abbott Labs

13.7

Y**

IBUPROFEN CHEWABLE TABLETS

McNeil

14.4

N

ESTRADIOL TRANSDERMAL SYSTEM

3M Pharm.

14.7

Y**

MENOTROPINS (FSH; LH)
LUTEINIZING HORMONE

Organon

14.9

Y**

GLIPIZIDE EXTENDED RELEASE

Pfizer

15.8

N**

 

 

Table 2, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

CLOBETASOL PROPIONATE GEL

Glaxo

16.4

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.7
FDA 2nd Action: 3.7(AP)

Y

Y

ISRADIPINE

Sandoz Pharmaceutical

17.0

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 4.8(AP)

Y

Y

TERAZOSIN HYDROCLORIDE

Abbott

17.6

FDA 1st Action: 12.9(AE)
Sponsor Response: 0.3
FDA 2nd Action: 4.4(AP)

N

Y

CLOBETASOL PROPIONATE CREAM

Glaxo

17.8

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.6
FDA 2nd Action: 5.2(AP)

Y

Y

IBUPROFEN 200 MG CAPSULES

Sandoz

18.7

N

FLUTICASONE PROPIONATE

Glaxo

18.8

FDA 1st Action: 16.8(AE)
Sponsor Response: 1.4
FDA 2nd Action: 0.6(AP)

N

Y

INDIUM IN-111 PENTETREOTIDE KIT

Mallinckrodt

19.3

N**

GRANISETRON HYDROCHLORIDE

SmithKline Beecham

19.5

FDA 1st Action: 7.1(NA)
Sponsor Response: 1.3
FDA 2nd Action: 5.7(AE)
Sponsor Response: 0.6
FDA 3rd Action: 4.9(AP)

Y

Y

Y

AMLODIPINE BESYLATE/BENAZEPRIL HYDROCHLORIDE

Ciba Geigy

20.1

FDA 1st Action: 13.0(AE)
Sponsor Response: 3.9
FDA 2nd Action: 3.2(AP)

Y**

Y

MAGNESIUM SULFATE

Abbott

20.1

FDA 1st Action: 6.9(NA)
Sponsor Response: 5.8
FDA 2nd Action: 7.4(AP)

Y

N

VARICELLA VIRUS VACCINE LIVE (PLA)

Merck & Co., Inc.

22.0

FDA 1st Action: 11.5(NA)
Sponsor Response: 1.5
FDA 2nd Action: 9.0(AP)

Y

N

ESTRADIOL

Ciba Geigy

22.1

FDA 1st Action: 15.0(AE)
Sponsor Response: 5.5
FDA 2nd Action: 1.7(AP)

Y**

Y

NISOLDIPINE

Zeneca

22.1

FDA 1st Action: 11.8(NA)
Sponsor Response: 4.3
FDA 2nd Action: 6.0(AP)

Y

Y

IOPAMIDOL

Johnson RW

22.3

FDA 1st Action: 12.5(NA)
Sponsor Response: 3.9
FDA 2nd Action: 5.9(AP)

N

Y

 

Table 2, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

DALTEPARIN SODIUM

Pharmacia

23.7

FDA 1st Action: 12.4(AE)
Sponsor Response: 9.0
FDA 2nd Action: 2.3(AP)

Y**

Y

†

IPRATROPIUM BROMIDE

Boehringer Ingelheim

24.2

FDA 1st Action: 11.6(NA)
Sponsor Response: 2.6
FDA 2nd Action: 6.0(AE)
Sponsor Response: 0.6
FDA 3rd Action: 3.4(AP)

Y

Y

Y

FAMOTIDINE

Merck

24.9

FDA 1st Action: 24.5(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.1(AP)

N**

Y

†

IPRATROPIUM BROMIDE

Boehringer Ingelheim

25.3

FDA 1st Action: 11.4(NA)
Sponsor Response: 4.0
FDA 2nd Action: 6.0(AE)
Sponsor Response: 0.6
FDA 3rd Action: 3.4(AP)

Y

Y

Y

DIRITHROMYCIN

Lilly

25.7

FDA 1st Action: 15.0(AE)
Sponsor Response: 7.0
FDA 2nd Action: 3.7(AP)

Y**

Y

MOEXIPRIL HYDROCHLORIDE

SPKU

28.0

FDA 1st Action: 17.0(AE)
Sponsor Response: 9.9
FDA 2nd Action: 1.1(AP)

N

Y

METRONIDAZOLE

Searle

28.6

FDA 1st Action: 12.0(AE)
Sponsor Response: 10.8
FDA 2nd Action: 5.8(AP)

Y**

Y

CARVEDILOL

SmithKline Beecham

29.5

N

†

NICOTINE SPRAY, METERED NASAL

Pharmacia

31.6

FDA 1st Action: 15.0(AE)
Sponsor Response: 10.6
FDA 2nd Action: 6.0(AP)

Y**

Y

CALCITONIN-SALMON

Sandoz

32.1

FDA 1st Action: 25.9(AE)
Sponsor Response: 1.2
FDA 2nd Action: 5.0(AP)

N

Y

†

TECHNETIUM TC-99M TETROFOSMIN KIT

Medi Physics

32.1

FDA 1st Action: 25.2(AE)
Sponsor Response: 2.3
FDA 2nd Action: 5.6(AP)

N

Y

CALCIUM MUPIROCIN

SmithKline Beecham

32.6

FDA 1st Action: 14.9(AE)
Sponsor Response: 3.8
FDA 2nd Action: 6.0(AE)
Sponsor Response: 3.1
FDA 3rd Action: 4.8(AP)

Y**

Y

Y

†

ADAPALENE

Galderma

34.4

N

 

Table 2, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (PLA)

Massachusetts Pulic Health Biologic Laboratories

35.0

FDA 1st Action: 5.4(NA)
Sponsor Response: 1.0
FDA 2nd Action: 6.5(NA)
Sponsor Response: 17.9
FDA 3rd Action: 4.2(AP)

Y

N

Y

†

DEXFENFLURAMINE HYDROCHLORIDE

Interneuron

35.2

FDA 1st Action: 20.8(NA)
Sponsor Response: 2.9
FDA 2nd Action: 11.5(AP)

N

N

†

IMMU-4 BULK (PLA)

Charles River Division of Wilimington Partners, L.P.

35.2

FDA 1st Action: 9.6(NA)
Sponsor Response: 10.9
FDA 2nd Action: 5.9(NA)
Sponsor Response: 3.6
FDA 3rd Action: 3.6(AE)
Sponsor Response: 0.5
FDA 4th Action: 1.0(AP)

Y

Y

Y

Y

†

IOXILAN

Cook Imaging

36.5

FDA 1st Action: 24.8(NA)
Sponsor Response: 5.7
FDA 2nd Action: 6.0(AP)

N

Y

†

IODIXANOL

Nycomed

36.6

FDA 1st Action: 30.1(AE)
Sponsor Response: 0.5
FDA 2nd Action: 6.0(AP)

N

Y

†

ADAPALENE

Galderma

38.2

N

†

CETIRIZINE HYDROCHLORIDE

Pfizer

44.4

FDA 1st Action: 32.2(AE)
Sponsor Response: 6.2
FDA 2nd Action: 6.0(AP)

N

Y

 

Table 3
Priority NDA and PLA Approvals—FY 94 Submissions
(Approvals from October 1, 1993—September 30, 1996)

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

ATOVAQUONE

Burroughs Wellcome

5.8

Y

GANCICLOVIR

Syntex

5.8

Y

STAVUDINE

Bristol Myers Squibb

5.9

Y

RIMEXOLONE

Alcon

7.0

Y

CYSTEAMINE BITARTRATE

Mylan

8.7

FDA 1st Action: 8.2(AE)
Sponsor Response: 0.4
FDA 2nd Action: 0.2(AP)

Y

Y

DORZOLAMIDE HYDROCHORIDE

Merck

12.0

Y

ABCIXIMAB (PLA)

Centocor B.V.

12.2

FDA 1st Action: 6.0(NA)
Sponsor Response: 1.7
FDA 2nd Action: 4.5(AP)

Y

Y

†

DOXORUBICIN HYDROCHLORIDE

Sequus Pharmaceuticals

14.3

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.6
FDA 2nd Action: 1.7(AP)

Y

Y

†

TRETINOIN

Roche

15.9

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.6
FDA 2nd Action: 3.3(AP)

Y

Y

ALPROSTADIL

UpJohn

16.7

FDA 1st Action: 11.9(NA)
Sponsor Response: 0.4
FDA 2nd Action: 4.4(AP)

Y

Y

EPOPROSTENOL SODIUM

Burroughs Wellcome

18.7

FDA 1st Action: 14.3(AE)
Sponsor Response: 2.6
FDA 2nd Action: 1.8(AP)

Y**

Y

†

DOCETAXEL

Rhone Poulenc

21.6

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.2
FDA 2nd Action: 5.3(AP)

Y**

Y

†

BENTOQUATAM

Enviroderm

22.9

FDA 1st Action: 12.0(NA)
Sponsor Response: 5.0
FDA 2nd Action: 6.0(AP)

Y

Y

 

Table 4
Standard NDA and PLA Approvals—FY 94 Submissions
(Approvals from October 1, 1993—September 30, 1996)

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

SEVOFLURANE

Abbott

10.9

Y

PLAGUE VACCINFE (PLA)

Greer Laboratories, Inc.

11.5

FDA 1st Action: 2.3(NA)
Sponsor Response: 1.2
FDA 2nd Action: 2.9(NA)
Sponsor Response: 2.4
FDA 3rd Action: 2.7(AP)

Y

Y

Y

CYCLOSPORINE MICROEMULSION SOLUTION

Sandoz

11.6

Y

CYCLOSPORINE MICROEMULSION CAPSULES

Sandoz

11.6

Y

NALMEFENE HYDROCHLORIDE

Ohmeda

11.6

Y

METRONIDAZOLE

Galderma

11.7

Y

IBUPROFEN ORAL DROPS

McNeil

11.8

Y

NAPROXEN

Syntex

11.9

Y

ACARBOSE

Bayer

12.0

Y

ESTROGENS, CONJUGATED/MEDROXYPROGESTRONE ACETATE

Wyeth Ayerst Labs

12.0

Y

IBUPROFEN 100 MG TABLETS

McNeil

12.0

Y

MAGNESIUM SULFATE

Abbott

12.0

Y

TESTOSTERONE TRANSDERMAL

Theratech

12.0

Y**

VALACYCLOVIR HCL

Burroughs Wellcome

12.0

Y

†

BICALUTAMIDE

Zeneca Pharm. Group

12.7

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.5(AP)

Y

Y

TIMOLOL HEMIHYDRATE

Leiras

13.4

FDA 1st Action: 10.4(NA)
Sponsor Response: 1.2
FDA 2nd Action: 1.9(AP)

Y**

Y

†

KETOPROFEN

Bayer Cons

14.6

FDA 1st Action: 12.0(AE)
Sponsor Response: 2.6
FDA 2nd Action: 0.0(AP)

DINOPROSTONE VAGINAL INSERT

Controlled Ther

15.0

Y**

†

GLIMEPIRIDE

Hoechst Roussel

15.0

Y**

 

Table 4, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

TRAMADOL HYDROCHLORIDE

Johnson RW

15.5

FDA 1st Action: 15.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.2(AP)

Y**

Y

ONDANSETRON HCL DIHYDRATE

Glaxo

15.8

FDA 1st Action: 6.6(NA)
Sponsor Response: 1.4
FDA 2nd Action: 4.9(AE)
Sponsor Response: 2.6
FDA 3rd Action: 0.4(AP)

Y

Y

Y

LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE

Merck

16.3

FDA 1st Action: 14.9(AE)
Sponsor Response: 1.3
FDA 2nd Action: 0.1(AP)

Y**

Y

LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE

Merck

16.6

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.6
FDA 2nd Action: 0.1(AP)

Y**

Y

LANSOPRAZOLE

Tap Holdings

17.8

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.9
FDA 2nd Action: 0.9(AP)

Y**

Y

AZELAIC ACID

Allergan

18.5

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.4
FDA 2nd Action: 6.0(AP)

Y

Y

†

TRANDOLAPRIL

Knoll Pharmaceuticals

18.9

FDA 1st Action: 11.9(AE)
Sponsor Response: 5.7
FDA 2nd Action: 1.3(AP)

Y

Y

AMIODARONE HYDROCHLORIDE

Wyeth Ayerst

19.2

FDA 1st Action: 13.5(AE)
Sponsor Response: 0.8
FDA 2nd Action: 1.6(AE)
Sponsor Response: 0.7
FDA 3rd Action: 2.6(AP)

Y**

Y

Y

†

PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE

Akorn

19.8

FDA 1st Action: 6.7(NA)
Sponsor Response: 6.4
FDA 2nd Action: 6.0(NA)
Sponsor Response: 0.2
FDA 3rd Action: 0.4(AP)

Y

Y

Y

†

CROMOLYN SODIUM

Medeva Pharms

20.1

FDA 1st Action: 3.0(AE)
Sponsor Response: 8.1
FDA 2nd Action: 3.9(AE)
Sponsor Response: 1.4
FDA 3rd Action: 3.7(AP)

Y

Y

Y

†

PORFIMER SODIUM

QLT

20.5

FDA 1st Action: 15.0(AE)
Sponsor Response: 4.8
FDA 2nd Action: 0.7(AP)

Y**

Y

†

NAPROXEN SODIUM

Elan

20.7

FDA 1st Action: 15.0(NA)
Sponsor Response: 5.0
FDA 2nd Action: 0.8(AP)

Y**

Y

 

Table 4, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

KETOPROFEN

Whitehall Robins

21.3

FDA 1st Action: 11.8(WD)
Sponsor Response: 2.7
FDA 2nd Action: 4.2(AE)
Sponsor Response: 2.3
FDA 3rd Action: 0.3(AP)

Y

Y

Y

†

ESTRADIOL

Pharmacia and Upjohn

21.9

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.2
FDA 2nd Action: 5.7(AP)

Y**

Y

CISAPRIDE

Janssen

22.5

FDA 1st Action: 9.2(NA)
Sponsor Response: 2.6
FDA 2nd Action: 7.5(AE)
Sponsor Response: 2.5
FDA 3rd Action: 0.6(AP)

Y

N

Y

†

ETOPOSIDE PHOSPHATE

Bristol Myers Squibb

22.7

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.8
FDA 2nd Action: 5.9(AP)

Y**

Y

†

TRIAMCINOLONE ACETONIDE

Rhone Poulenc Rorer

22.7

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.7
FDA 2nd Action: 6.0(AP)

Y**

Y

†

DICLOFENAC SODIUM

Geigy Pharmaceuticals

22.9

FDA 1st Action: 15.0(NA)
Sponsor Response: 2.1
FDA 2nd Action: 5.8(AP)

Y**

Y

†

AZITHROMYCIN DIHYDRATE

Pfizer

23.7

FDA 1st Action: 15.0(AE)
Sponsor Response: 3.2
FDA 2nd Action: 5.6(AP)

Y

Y

†

BUTOCONAZOLE NITRATE

Syntex Labs

24.0

FDA 1st Action: 13.5(NA)
Sponsor Response: 6.9
FDA 2nd Action: 3.6(AP)

Y

Y

†

IPRATROPIUM BROMIDE

Boehringer Ingelheim

24.2

FDA 1st Action: 11.6(NA)
Sponsor Response: 2.6
FDA 2nd Action: 6.0(AE)
Sponsor Response: 0.6
FDA 3rd Action: 3.4(AP)

Y

Y

Y

†

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

Schering

26.9

FDA 1st Action: 12.0(AE)
Sponsor Response: 1.4
FDA 2nd Action: 6.0(AE)
Sponsor Response: 1.6
FDA 3rd Action: 6.0(AP)

Y

Y

Y

†

LORATADINE/PSEUDOEPHEDRINE SULFATE

Schering

28.2

FDA 1st Action: 12.0(NA)
Sponsor Response: 10.3
FDA 2nd Action: 6.0(AP)

Y

Y

 

Table 4, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

NOFETUMOMAB (PLA)

Dr. Karl Thomae GmbH

28.7

FDA 1st Action: 8.9(NA)
Sponsor Response: 3.2
FDA 2nd Action: 5.6(NA)
Sponsor Response: 1.3
FDA 3rd Action: 5.9(NA)
Sponsor Response: 2.4
FDA 4th Action: 1.3(AP)

Y

Y

Y

Y

†

AZITHROMYCIN DIHYDRATE

Pfizer

29.0

FDA 1st Action: 11.9(AE)
Sponsor Response: 9.2
FDA 2nd Action: 6.0(AE)
Sponsor Response: 1.0
FDA 3rd Action: 0.9(AP)

Y

Y

Y

†

NILUTAMIDE

Roussel Uclaf

30.5

FDA 1st Action: 12.0(AE)
Sponsor Response: 5.5
FDA 2nd Action: 6.0(AE)
Sponsor Response: 0.9
FDA 3rd Action: 6.0(AP)

Y

Y

Y

†

MEROPENEM

Zeneca Pharmaceutical Group

30.7

FDA 1st Action: 12.0(NA)
Sponsor Response: 12.8
FDA 2nd Action: 5.9(AP)

Y

Y

†

FERUMOXIDES

Adv Magnetics

30.7

FDA 1st Action: 23.8(AE)
Sponsor Response: 2.0
FDA 2nd Action: 4.9(AP)

Y

Y

 

Table 5
Priority NDA and PLA Approvals—FY 95 Submissions
(Approvals from October 1, 1994—September 30, 1996)

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

SAQUINAVIR MESYLATE

Roche

3.2

Y

†

LAMIVUDINE TABLETS

Glaxo Wellcome

4.4

Y

†

LAMIVUDINE SOLUTION (ORAL)

Glaxo Wellcome

4.4

Y

†

RILUZOLE

Rhone Poulenc

5.5

FDA 1st Action: 4.8(AE)
Sponsor Response: 0.4
FDA 2nd Action: 0.3(AP)

Y

Y

MYCOPHENOLATE MOFETIL

Syntex

5.7

Y

†

AMPHOTERICIN B

Liposome

5.9

Y

ALENDRONATE SODIU,

Merck

6.0

Y

†

GANCICLOVIR STERILE INTRAVITREAL IMPLANT

Chiron Vision

7.8

Y

†

SOMATROPIN INJECTABLE 6MG

Serono Laboratories

11.4

Y

†

LATANOPROST

Pharmacia and Upjohn

11.7

Y

†

INTERFERON BETA-1A (PLA)

Biogen, Inc.

11.8

Y

†

IMCIROMAB PENTETATE (PLA)

Centocor B.V.

11.9

Y

†

SODIUM PHENYLBUTYRATE POWDER

Ucyclyd

14.4

FDA 1st Action: 12.0(AE)
Sponsor Response: 2.2
FDA 2nd Action: 0.2(AP)

Y

Y

†

SODIUM PHENYLBUTYRATE TABLETS

Ucyclyd

14.8

FDA 1st Action: 12.0(AE)
Sponsor Response: 2.2
FDA 2nd Action: 0.7(AP)

Y

Y

†

GEMCITABINE HYDROCHLORIDE

Lilly

15.4

FDA 1st Action: 15.0(AE)
Sponsor Response: 0.4
FDA 2nd Action: 0.1(AP)

Y**

Y

 

Table 6
Standard NDA and PLA Approvals—FY 95 Submissions
(Approvals from October 1, 1994—September 30, 1996)

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

CMV HIGH TITER FRACTION II+III PASTE (PLA)

Baxter Healthcare Corp.

0.3

Y

†

IOHEXOL

Nycomed

5.5

Y

†

SELEGILINE HYDROCHLORIDE

Somerset Pharmaceuticals

8.7

Y

†

ANASTROZOLE

Zeneca Pharmaceuticals

9.0

Y

†

DOPAMINE HYDROCHLORIDE IN 5% DEXTROXE INJECTION

Abbott

9.4

Y

†

REMIFENTANIL HYDROCHLORIDE

Glaxo Wellcome

9.9

Y

†

AMOXICILLIN/CLAVULANATE POTASSIUM POWDER FOR ORAL SOLUTION

SmithKline Beecham

10.4

Y

†

LIDOCAINE HYDROCHLORIDE/EPINEPHRINE

Iomed

10.9

Y

†

NIMBEX INJECTABLE 2 MG/ML 20 MG/ML

Glaxo Wellcome

11.3

Y

†

ZIDOVUDINE

Glaxo Wellcome

11.4

Y

†

OXYCODONE HYDROCHLORIDE

Purdue Frederick

11.5

Y

†

LIDOCAINE

Noven Pharmaceuticals

11.7

Y

†

MORPHINE SULFATE CAPSULES

Faulding Pharmaceuticals (US)

11.8

Y

†

FEXOFENADINE HYDROCHLORIDE

Hoechst Marion Roussel

11.8

Y

†

MORPHINE SULFATE INJECTABLE

Mallinckrodt

11.9

Y

†

RSV HIGH TITER FRACTION II+III PASTE (PLA)

Baxter Healthcare Corp.

11.9

Y

†

LEUPROLIDE ACETATE

Tap Holdings

12.0

Y

†

ESTROGENS CONJUGATED/MEDROXYPROGESTERONE ACETATE

Wyeth Ayerst Laboratories

12.0

Y

 

Table 6, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

LEVONORGESTREL

Wyeth Ayerst Laboratories

12.0

Y

†

SOYBEAN OIL

Pharmacia and Upjohn

12.0

Y

†

BRIMONIDINE TARTRATE

Allergan

12.0

Y

†

RISPERIDONE

Janssen

12.3

FDA 1st Action: 11.6(AE)
Sponsor Response: 0.1
FDA 2nd Action: 0.6(AP)

Y

Y

†

OLANZAPINE

Lilly

12.3

FDA 1st Action: 11.3(AE)
Sponsor Response: 0.6
FDA 2nd Action: 0.4(AP)

Y

Y

†

PROCAINAMIDE HYDROCHLORIDE

Parke Davis

13.3

FDA 1st Action: 11.7(AE)
Sponsor Response: 0.1
FDA 2nd Action: 1.4(AP)

Y

Y

†

VERAPAMIL HYDROCHLORIDE

Searle

13.3

FDA 1st Action: 12.0(AE)
Sponsor Response: 1.1
FDA 2nd Action: 0.2(AP)

Y

Y

†

SOMATROPIN (RDNA ORIGIN)

Genentech Inc.

13.5

FDA 1st Action: 12.0(NA)
Sponsor Response: 0.3
FDA 2nd Action: 1.2(AP)

Y

Y

†

IBUPROFEN

McNeil Consumer Products

13.6

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.7
FDA 2nd Action: 0.9(AP)

Y

Y

†

IBUTILIDE FUMARATE

Pharmacia and Upjohn

14.0

Y**

†

RANITIDINE HYDROCHLORIDE

Glaxo Wellcome

14.0

FDA 1st Action: 12.2(AE)
Sponsor Response: 0.3
FDA 2nd Action: 1.5(AP)

Y**

Y

†

BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE

Procter and Gamble

14.4

FDA 1st Action: 12.0(AE)
Sponsor Response: 2.1
FDA 2nd Action: 0.3(AP)

Y

Y

†

FLUTICASONE PROPIONATE

Glaxo Wellcome (US)

14.9

Y**

†

GOSERELIN ACETATE

Zeneca (UK)

14.9

Y**

†

CLEMASTINE FUMARATE/PHENYLPROPANOLAMINE HYDROCHLORIDE

Sandoz Pharmaceuticals

15.0

Y**

†

HEPATITIS A VACCINE INACTIVATED (PLA)

Merck & Co., Inc.

15.0

Y**

†

INSULIN LISPRO

Lilly

15.0

Y**

†

ALBUTEROL SULFATE

3M Pharmaceuticals

15.0

Y**

 

Table 6, Continued

Generic Name

Sponsor

Approval Time (Months)

Review
Goal
Met

Total Time*

Resubmissions
(if necessary)

†

ZAFIRLUKAST

Zeneca

15.0

Y**

†

AMOXICILLIN/CLAVULANATE POTAASIUM TABLETS

SKB Pharmaceuticals

15.6

FDA 1st Action: 11.9(NA)
Sponsor Response: 0.4
FDA 2nd Action: 3.3(AP)

Y

Y

†

UREA, C-13

Meretek

16.3

FDA 1st Action: 12.0(NA)
Sponsor Response: 1.7
FDA 2nd Action: 2.6(AP)

Y

Y

†

MIRTAZAPINE

Organon

16.5

FDA 1st Action: 11.9(AE)
Sponsor Response: 1.7
FDA 2nd Action: 2.9(AP)

Y

Y

†

NIZATIDINE

Whitehall Robins

16.6

FDA 1st Action: 11.3(AE)
Sponsor Response: 0.7
FDA 2nd Action: 4.6(AP)

Y

Y

†

FOSPHENYTOIN SODIUM

Parke Davis

17.4

FDA 1st Action: 12.0(AE)
Sponsor Response: 1.7
FDA 2nd Action: 3.7(AP)

Y

Y

†

TERBINAFINE HYDROCHLORIDE

Sandoz

17.6

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.7
FDA 2nd Action: 4.9(AP)

Y

Y

†

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

Astra USA

17.9

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.0
FDA 2nd Action: 2.0(AP)

Y**

Y

†

CALCIPOTRIENE

Bristol Myers Squibb

18.8

FDA 1st Action: 12.0(AE)
Sponsor Response: 0.8
FDA 2nd Action: 6.0(AP)

Y

Y

†

RANITIDINE BISMUTH CITRATE

Glaxo Wellcome

19.3

FDA 1st Action: 15.0(AE)
Sponsor Response: 2.9
FDA 2nd Action: 1.4(AP)

Y**

Y

†

ESTRADIOL FILM CONTROLLED RELEASE

Menorest

21.5

FDA 1st Action: 12.0(AE)
Sponsor Response: 3.5
FDA 2nd Action: 6.0(AP)

Y

Y

†

AMMONIUM LACTATE

Bristol Myers

22.4

FDA 1st Action: 15.0(AE)
Sponsor Response: 1.4
FDA 2nd Action: 6.0(AP)

Y**

Y