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FY 1996 PDUFA Performance Report

Print version of this Report


TABLE OF CONTENTS

 

Purpose

Commissioner's Report

Report on FY 1996 PDUFA Goals

Discussion of Performance in FY 1996

Notes 

Appendices:

Appendix A: PDUFA Performance Goals 

Appendix B: Approval


 

 

PURPOSE

 

The Prescription Drug User Fee Act of 1992 (PDUFA), Public Law 102-571, authorized revenues from fees paid by the pharmaceutical industry to expedite review by the Food and Drug Administration (FDA) of human drug applications. These revenues were directed by section 102(3) of this Act toward accomplishment of goals identified in the letters of September 14 and 21, 1992 from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate (as set forth at 138 Congressional Record H9099-H9100: daily edition of September 22, 1992).

 

Section 104 of the Act requires FDA to submit two annual reports to Congress for each fiscal year during which fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report due within 120 days of the end of the fiscal year. This document fulfills the first of these requirements for Fiscal Year 1996. It reports on progress toward four FY 96 submission review goals, and updates performance on the FY 95 submission goals.

 


 

COMMISSIONER'S REPORT

 

 

 

 

On-Time Review Performance FY95 Submissions

 

 

 

 

Goal
Actual
Original NDAs/
PLAs/ElAs

 

70%

 

95%
Efficacy Supplements

 

70%

 

93%
Manufacturing Supplements

 

70%

 

89%
Resubmissions

 

70%

 

96%

 

Four years ago, Congress enacted the Prescription Drug User Fee Act of 1992 which set increasingly stringent annual review goals for FDA and provided the resources to meet those goals. It is now clear that PDUFA has produced much more than its stated objectives. It is having a dramatic effect on the number of new products reaching the market and the speed with which they get there.

 

Again this year, the Agency has exceeded all the performance goals. The table to the left summarizes that performance, and the body of this report provides the details. What I want to emphasize, however, are the more profound and important results that are beginning to emerge. Just as the Agency has improved under PDUFA, so has the industry. Sponsors are submitting more new product applications to the Agency, and the quality of these submissions is greatly improved. As a result, more review decisions are positive, and record proportions of submissions are proceeding to approval.

 

PDUFA is a success. The Agency and the industry have forged a working relationship based on a commitment to excellence which is producing measurable benefits for the American consumer.

 

David A. Kessler, M.D.
Commissioner of Food and Drugs

 

 

 


 

 

 

REPORT ON
FY 1996 PDUFA GOALS

 

Twenty-nine performance-based goals constitute the management framework for PDUFA. These goals, listed by fiscal year in Appendix A, span the five-year term of the statute. Collectively, they direct management efforts toward three broad priorities: eliminating overdue backlogs, building excellence into the review process, and achieving measurable, high performance.

 

Eighteen of the goals have been reported in previous years' performance reports. Four goals remain for FY 96 and seven for FY 97. The FY 96 goals specify review performance targets for the submissions received subject to PDUFA during FY 96. Final review performance results on submissions received during a fiscal year cannot be determined fully at the end of that fiscal year. The review goals for original NDAs, PLAs, and ELAs and for efficacy supplements specify a 12-month review period. For most FY 96 submissions, the 12-month review period obviously has not yet occurred. In contrast, nearly all of the FY 95 submissions have been reviewed, and Agency performance on those submissions can now be evaluated.

 

This report uses the FY 90 and FY 91 submissions as a pre-PDUFA baseline for evaluating longer term changes. The baseline omits FY 92 because some PDUFA measures extend into the last month of FY 92, and the processing of most FY 92 submissions benefited from post-PDUFA process improvements. Some CBER pre-PDUFA comparisons are not possible due to the imprecise distinction between an original biologic application and its resubmission before PDUFA.

 

 

 


 

 

 

Goal 1

.

 

 

.

 

 

 

 

 

Review and act upon complete NDA, PLA and ELA submissions within 12 months of submission date:

 

FY 94 Submissions: 55 percent on-time
FY 95 Submissions: 70 percent on-time
FY 96 Submissions: 80 percent on-time

Original NDAs, PLAs, and ELAs Filed:

 

 

 

FY932

 

FY94

 

FY95

 

FY963

 

 

NDAs

 

81

 

90

 

106

 

116

 

 

PLA

 

7+8

 

4+5

 

12+7

 

9+6

 

 

PDUFA Total

 

96

 

99

 

125

 

131

 

Performance on FY 95 submissions:

  • Combined CDER/CBER on-time performance is currently 95 percent. Could reach 99 percent if 5 pending submissions are reviewed within time frame
  • Performance exceeds FY95's 70 percent goal
  • Proportion of submissions reviewed on-time more than doubles the pre-PDUFA performance level of 42 percent
  • Only one submission has failed to meet the performance goal -- an NDA that was three days late

Performance on FY 96 submissions:

  • On-time review performance will exceed the PDUFA standard of 80 percent based on year-to-year performance trends
  • Final review performance assessment will occur on December 31, 1997
  • As of October 1, 1996, 16 percent of applications had been acted upon (all within goal)

 

 

 


 

 

 

Goal 2

.

 

.

 

 

 

 

 

Review and act upon efficacy supplements4 to NDAs and PLAs within 12 months of submission date:

 

FY 94 Submissions: 55 percent on-time
FY 95 Submissions: 70 percent on-time
FY 96 Submissions: 80 percent on-time

 

Efficacy Supplements Filed:

 

 

 

FY932

 

FY94

 

FY95

 

FY963

 

 

to NDAs

 

92

 

86

 

77

 

101

 

 

to PLAs

 

8

 

6

 

10

 

8

 

 

PDUFA Total

 

100

 

92

 

87

 

109

 

Performance on FY 95 submissions:

  • Combined CDER/CBER on-time performance is 93 percent
  • Performance exceeds FY95's 70 percent goal
  • Proportion of submissions reviewed within a 12-month time frame nearly triples the pre-PDUFA performance level of 33 percent
  • Combined CDER/CBER performance improves over FY93's 42 percent on-time rate (no goal in effect) and FY94's 77 percent rate

Performance on FY 96 submissions:

  • On-time review performance will exceed the PDUFA performance standard of 80 percent based on year-to-year performance trends
  • Final review performance assessment will occur on September 30, 1997
  • As of October 1, 1996, 20 percent of submissions had been acted upon
    (all within goal)

 

 

 


 

 

 

Goal 3

 

.

 

.

 

 

 

 

Review and act upon manufacturing supplements to NDAs, PLAs and ELAs within 6 months of submission date:

 

FY 94 Submissions: 55 percent on-time
FY 95 Submissions: 70 percent on-time
FY 96 Submissions: 80 percent on-time

Manufacturing Supplements Filed:

 

 

 

FY932

 

FY94

 

FY95

 

FY963

 

 

to NDAs

 

1,045

 

872

 

1,251

 

1,232

 

 

to PLAs, ELAs

 

203

 

186

 

268

 

262

 

 

PDUFA Total

 

1,248

 

1,058

 

1,519

 

1,494

 

Performance on FY 95 submissions:

  • Combined CDER/CBER on-time performance is 89 percent
  • Performance exceeds FY 95's 70 percent goal
  • Combined CDER/CBER performance improves over FY 93's 51 percent on-time rate (no goal in effect) and FY 94's 69 percent rate

Performance on FY 96 submissions:

  • FY96 bars in charts depict on-time performance on supplements received during first half of FY 96. Since review goal is 6 months, this is an early indicator of final FY 96 performance
  • Combined CDER/CBER on-time performance through first 6 months is 96 percent
  • Final on-time performance projected to exceed FY 96's 80 percent goal
  • Combined CDER/CBER projected performance improves over FY95's 89 percent on-time rate
  • Final review performance assessment will occur on March 31, 1997

 

 

 

 


 

 

 

Goal 4

.

 

 

.

 

 

 

 

 

Review and act upon resubmitted NDAs, PLAs and ELAs within 6 months of resubmission date:

 

FY 94 Submissions: 55 percent on-time
FY 95 Submissions: 70 percent on-time
FY 96 Submissions: 80 percent on-time

Resubmissions Received:

 

 

 

FY93

 

FY94

 

FY95

 

FY96

 

 

of Original NDAs

 

2

 

24

 

58

 

89

 

 

of Original PLAs

 

1

 

13

 

11

 

18

 

 

PDUFA Total

 

3

 

37

 

71

 

106

 

Performance on FY 95 resubmissions:

  • Combined CDER/CBER on-time performance is 96 percent
  • Performance exceeds FY 95's 70 percent goal
  • Combined CDER/CBER performance improves over FY 94's 81 percent on-time rate

Performance on FY 96 resubmissions:

  • FY96 bars in charts depict on-time performance on resubmissions received during first half of FY 96. Since review goal is 6 months, this is an early indicator of final FY 96 performance
  • Combined CDER/CBER on-time performance through first 6 months is 98 percent
  • Final on-time performance projected to exceed FY 96's 80 percent goal
  • Combined CDER/CBER projected performance improves over FY95's 89 percent on-time rate
  • Final review performance assessment will occur on March 31, 1997

 

 

 


 

 

DISCUSSION OF PERFORMANCE
DURING FY96

 

As the fourth year of PDUFA ends, its success is apparent. The cumulative effects of additional human and financial resources, the use of project management methodology to guide the review process and monitor the increasing workload, the elimination of the backlogs, and the increased emphasis on timeliness as a performance measure, are resulting in significantly improved Agency and industry performance, predictability, and accountability. In FY 96, FDA approved a record 131 NDAs and PLAs -- a substantial increase over the 84 in FY 95 and the 67 in FY 94.

 

The record number of approvals is but one sign of an improved working relationship between sponsors and the Agency. PDUFA has resulted in better applications which can be accepted immediately and reviewed more quickly. Ultimately, new products get on the market faster. These changes can be documented by empirical evidence.

 

Better Initial Submissions: A key measure of submission quality is the "Refuse to File" rate. As of October 1, 1996, only 6 NDAs/PLAs/ELAs submitted in FY 96 had been refused. These numbers compare with nine RTFs total for the FY 95 submissions, and are much lower than the 25 RTFs for the FY 94 submissions and 34 for FY 93. Because so few initial submissions are refused, more applications are going directly into the review process.

 

Higher Rates of Positive First Actions: The proportion of first reviews that result in positive (i.e., "Approved" or "Approvable") decisions is another measure of submission quality and another key factor in achieving timely approvals. For original NDAs, PLAs, and ELAs submitted in FY 95, this measure rose to a 67 percent rate which is a substantial increase over the 48 percent rate experienced only one year ago (FY 94). As a result, comparatively few eventually approved applications go through time-consuming major revisions in response to "Not Approvable" decisions by FDA.

 

Faster Action on Resubmissions: Sponsor response times to initial decisions (other than "Approved") and Agency decisions following the resubmissions continue to accelerate. In response to initial FDA decisions on FY 95 submissions, sponsors resubmitted NDA and PLA applications to the Agency in an average of 1.2 months. The Agency reviewed these resubmissions and issued action letters in an average of 2.2 months after resubmission. For FY 95 submissions, total elapsed time from initial decision to approval averaged 3.4 months which is less than half the 8.4 months experienced on resubmissions of FY 94 applications. Further details on resubmission performance are provided in Appendix B.

 

Increasing Approval Rates: Another indication of improved submission quality is the increase in the percentage of submissions that are ultimately approved. For the years immediately preceding PDUFA, roughly 56 percent of the original submissions were approved. To date, 55 percent of the FY 95 submissions (65 NDAs and PLAs) have been approved and another 18 percent (20) are "approvable" or "pending" following an initial "approvable" decision. The final approval rate for the FY 95 submissions will approach 80 percent. The final approval rates for the FY 94 and FY 93 submissions are also high by historical standards and should reach 75 percent.

 

Quicker Approval Times: The ultimate approval times for applications submitted during the PDUFA years continue to decline from the 23 month median typical of the early 1990's.7

 

Submission Year

 

FY93

 

FY94

 

FY95
Median Months to Approval

 

19.0

 

18.5

 

15.0

 

Progress on Priority Applications: Beginning with the FY 97 submissions, 90 percent of the priority NDAs, PLAs, and ELAs must be reviewed and acted upon within six months. Even though there was no separate goal for priority applications submitted prior to FY 97, some progress is already evident. In the first half of FY 96, FDA received 18 priority applications. Ten of these (56 percent) were reviewed within 6 months. This is an improvement over the 33 percent rate for priority applications received in FY 95 and the 37 percent rate for FY 94's receipts, but it is still well below the 90 percent goal that is in effect for the FY 97 submissions. Notes:

 

 

 

 


Notes:

1. The PDUFA agreements allow for one 3-month extension of the review time if there is a major amendment to an original NDA, PLA, or ELA submission in month 10, 11, or 12 of the first review cycle. A submission that was received in late FY 95 that received such a major amendment could have as its PDUFA review goal a date in December 1996. This extension is not allowed for efficacy supplements, manufacturing supplements, or resubmissions.

2. FY 93 was a 13-month fiscal year including September 1992. Calculations of annual changes in workload extrapolate counts downward to a 12-month year.

3. The count of FY 96 submissions assumes that all submissions received in the last two months of FY 96 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA determines the "fileability" of an application within 60 days of its original receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.

4. The term "supplement" applies to both drug and biologic submissions. It includes the former term of "amendments" to biologic submissions.

5. A resubmission is a firm's response after an FDA action of "approvable" or "not approvable" on an application. The applicable performance goal for a resubmission is determined by the year in which the resubmission itself is received, rather than its original application's year. This explains the relatively low number of resubmissions in the early PDUFA years.

6. Source: United States General Accounting Office, FDA Drug Approval: Review Time Has Decreased in Recent Years (GAO/PEMD-96-1), October 1995.

7. The calculation of the ultimate median approval times for the PDUFA years is based upon final approval rates of 75 % for FY 93 and FY 94 submissions and 80 % for FY 95. Although the last approvals for these submission years have not yet occurred the median statistic can be computed from approvals to date.

 


APPENDIX A: PDUFA PERFORMANCE GOALS, FY 1993 - FY 1997

The following list presents by fiscal year the performance measures set forth in the letters referenced in Section 102(3) of the PDUFA. In those letters, the timing of a number of the goals was conditional either (l) on the date (July 2, 1993) upon which a supplemental appropriation was enacted to permit FDA to collect PDUFA user fees, or (2) a specific performance interval (e.g., 6 or 12 months after submission). The following chart lists the 29 goals by fiscal year with appropriate goal measurement dates:

 

INTERIM GOALS BY FISCAL YEAR

 

TIMING OF MEASUREMENT

 

MEASUREMENT DATE1
INTERIM GOALS OF FY 93  
1. Establish an industry/FDA working group upon initiation of the user fee program.Supplemental appropriation dateJuly 2, 1993
2. Initiate a pilot computer-assisted PLA review (CAPLAR) program during FY 93.End of FY 93Sept. 30, 1993

 

INTERIM GOALS OF FY 94  
1. Review and act upon 55 percent of complete NDA and PLA/ELA submissions received during FY 94 within 12 months after submission date.12 months after end of FY 94Sept. 30, 1995
2. Review and act upon 55 percent of efficacy supplements2 received during FY 94 within 12 months after submission date.12 months after end of FY 94Sept. 30, 1995
3. Review and act upon 55 percent of manufacturing supplements2 received during FY 94 within 6 months after submission date.6 months after end of
FY 94
Mar. 31, 1995
4. Review and act upon 55 percent of resubmitted applications received during FY 94 within 6 months after the resubmission date.6 months after end of
FY 94
Mar. 31, 1995
5. Implement performance tracking and monthly monitoring of CBER performance within 6 months of initial user fee payments.6 months after 7/2/93Jan. 2, 1994
6. Implement project management methodology for all NDA reviews within 12 months of the initiation of user fee payments.12 months after 7/2/93July 2, 1994

 


 

 

 

INTERIM GOALS OF FY 95  
1 Review and act upon 70 percent of complete NDA and PLA/ELA submissions received during FY 95 within 12 months after submission date.12 months after end of FY 95Sept. 30, 1996
2. Review and act upon 70 percent of efficacy supplements received during FY 95 within 12 months after submission date.12 months after end of FY 95Sept. 30, 1996
3. Review and act upon 70 percent of manufacturing supplements received during FY 95 within 6 months after submission date.6 months after end of FY 95Mar. 31, 1996
4. Review and act upon 70 percent of resubmitted applications received during FY 95 within 6 months after the resubmission date.6 months after end of FY 95Mar. 31, 1996
5. Recruit and bring on board 50 percent of FDA incremental review staff by first quarter of FY 953 months after end of FY 94Dec. 31, 1994
6. Implement project management methodology for all PLA/ELA reviews within 18 months of user fee payments18 months after 7/2/93Jan. 2, 1995
7. Eliminate overdue backlogs of efficacy and manufacturing supplements to NDAs within 18 months of initiation of user fee payments.18 months after 7/2/93Jan. 2, 1995
8. Eliminate overdue backlog of NDAs within 24 months of initiation of user fees.24 months after 7/2/93July 2, 1995
9. Eliminate overdue backlog of PLAs, ELAs, and PLA/ELA supplements within 24 months of initiation of user fees.24 months after 7/2/93July 2, 1995
10. Adopt uniform computer assisted NDA standards during FY 95.End of FY 95Sept. 30, 1995

 

INTERIM GOALS OF FY 96   
1. Review and act upon 80 percent of complete NDA and PLA/ELA submissions received during FY 96 within 12 months after submission date.12 months after end of FY 96Sept. 30, 1997 
2. Review and act upon 80 percent of efficacy supplements received during FY 96 within 12 months after submission date.12 months after end of FY 96Sept. 30, 1997 
3. Review and act upon 80 percent of manufacturing supplements received during FY 96 within 6 months after submission date.6 months after end of FY 96Mar. 31, 1997 
4. Review and act upon 80 percent of resubmitted applications received during FY 96 within 6 months after the resubmission date.6 months after end of FY 96Mar. 31, 1997 

 


 

 

 

INTERIM GOALS OF FY 97  
1. Review 90 percent of complete PLAs, ELAs and NDAs for priority applications within 6 months after submission date.6 months after end of FY 97Mar. 31, 1998
2. Review 90 percent of complete PLAs, ELAs and NDAs for standard applications within 12 months after submission date.12 months after end of FY 97Sept. 30, 1998
3. Review 90 percent of priority supplements to PLAs, ELAs, and NDAs within 6 months after submission date.6 months after end of FY 97Mar. 31, 1998
4. Review 90 percent of standard supplements to PLAs, ELAs and NDAs that require review of clinical data (efficacy supplements) within 12 months after submission.12 months after end of FY 97Sept. 30, 1998
5. Review 90 percent of supplements to PLAs, ELAs and NDAs that do not require review of clinical data (e.g., manufacturing supplements) within 6 months after submission date.6 months after end of FY 97Mar. 31, 1998
6. Review 90 percent of complete applications resubmitted following receipt of a non-approval letter within 6 months after the resubmission date.6 months after end of FY 97Mar. 31, 1998
7. Total review staff increment recruited and on board by end of FY 97.End of FY 97Sept. 30, 1997

 

 

NOTES

 

1. The statute allows three additional months for review of original NDA, PLA, or ELA submissions that involve major amendments within the last three months of their usual 6- or 12-month review intervals. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

2. The term "supplement" applies to both drug and biologic submissions. It includes "amendments" to biologic submissions.

 


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 HCLBiodevelopment

 

0.6
 

 

Y
 FENTANYL CITRATEAnesta

 

4.3
 

 

Y
 TACROLIMUS INJECTABLEFujisawa USA

 

8.1
 

 

Y
 TACROLIMUS CAPSULESFujisawa USA

 

8.4
 

 

Y
 DORNASE ALFA (PLA)Genentech, INC.

 

9.0
 

 

Y
 IMIGLUCERASEGenzyme

 

12.1
 

 

N
 APROTININMiles Pharmaceutical

 

13.2
FDA 1st Action: 7.2(AE)
Sponsor Response: 5.5
FDA 2nd Action: 0.5(AP)

 

Y

 

 

Y
 METFORMIN HYDROCHLORIDEBristol Myers Squibb

 

15.0
 

 

Y**
 VINORELBINE TARTRATEBurroughs Wellcome

 

15.9
FDA 1st Action: 14.9(AE)
Sponsor Response: 0.3
FDA 2nd Action: 0.7(AP)

 

Y**

 

 

Y
 FLUDEOXYFLUCOSE F-18Downstate Clinical

 

19.0
 

 

N
 MILRINONE LACTATESterling 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 CITRATENexstar

 

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 ESTRADIOLJohnson RW

 

2.2
 

 

Y
 SOMATROPIN, BIOSYNTHETICGenetech, Inc.

 

4.2
 

 

Y
 DOBUTAMINE HYDROCHLORIDEBaxter Healthcare

 

6.9
FDA 1st Action: 3.2(NA)
Sponsor Response: 3.1
FDA 2nd Action: 0.6(AP)

 

Y

 

 

Y
 ROCURONIU, BROMIDEOrganon

 

8.6
FDA 1st Action: 6.4(AE)
Sponsor Response: 1.0
FDA 2nd Action: 1.2(AP)

 

Y

 

 

Y
 TRIMETREXATEU.S. Bioscience

 

10.5
 

 

Y
 CLOTRIMAZOLEMiles Pharmaceutical

 

10.4
FDA 1st Action: 7.3(AE)
Sponsor Response: 0.6
FDA 2nd Action: 2.4(AP)

 

Y

 

 

Y
 TIMOLOL MALEATEMerck

 

10.9
FDA 1st Action: 6.5(AE)
Sponsor Response: 1.1
FDA 2nd Action: 3.3(AP)

 

Y

 

 

Y
 DESMOPRESSIN ACETATERhone Poulenc Rorer

 

11.5
 

 

Y
 FAMCICLOVIRSmithKline Beecham

 

12.0
 

 

Y
 ISONIAZID/PYRAZINAMIDE/RIFAMPINMarion Merrell

 

12.4
 

 

N
 NAPROXEN SODIUMHamilton

 

12.8
 

 

N
 BUDESONIDEAstra

 

13.5
FDA 1st Action: 11.5(AE)
Sponsor Response: 0.4
FDA 2nd Action: 1.5(AP)

 

Y

 

 

Y
 CLARITHROMYCINAbbott Labs

 

13.7
 

 

Y**
 IBUPROFEN CHEWABLE TABLETSMcNeil

 

14.4
 

 

N
 ESTRADIOL TRANSDERMAL SYSTEM3M Pharm.

 

14.7
 

 

Y**
 MENOTROPINS (FSH; LH)
LUTEINIZING HORMONE
Organon

 

14.9
 

 

Y**
 GLIPIZIDE EXTENDED RELEASEPfizer

 

15.8
 

 

N**

 

 


 

 

Table 2, Continued
 

 

Generic Name

 

Sponsor

 

Approval Time (Months)

 

Review
Goal
Met

 

Total Time*

 

Resubmissions
(if necessary)
 CLOBETASOL PROPIONATE GELGlaxo

 

16.4
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.7
FDA 2nd Action: 3.7(AP)

 

Y

 

 

Y
 ISRADIPINESandoz Pharmaceutical

 

17.0
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 4.8(AP)

 

Y

 

 

Y
 TERAZOSIN HYDROCLORIDEAbbott

 

17.6
FDA 1st Action: 12.9(AE)
Sponsor Response: 0.3
FDA 2nd Action: 4.4(AP)

 

N

 

 

Y
 CLOBETASOL PROPIONATE CREAMGlaxo

 

17.8
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.6
FDA 2nd Action: 5.2(AP)

 

Y

 

 

Y
 IBUPROFEN 200 MG CAPSULESSandoz

 

18.7
 

 

N
 FLUTICASONE PROPIONATEGlaxo

 

18.8
FDA 1st Action: 16.8(AE)
Sponsor Response: 1.4
FDA 2nd Action: 0.6(AP)

 

N

 

 

Y
 INDIUM IN-111 PENTETREOTIDE KITMallinckrodt

 

19.3
 

 

N**
 GRANISETRON HYDROCHLORIDESmithKline 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 HYDROCHLORIDECiba Geigy

 

20.1
FDA 1st Action: 13.0(AE)
Sponsor Response: 3.9
FDA 2nd Action: 3.2(AP)

 

Y**

 

 

Y
 MAGNESIUM SULFATEAbbott

 

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
 ESTRADIOLCiba Geigy

 

22.1
FDA 1st Action: 15.0(AE)
Sponsor Response: 5.5
FDA 2nd Action: 1.7(AP)

 

Y**

 

 

Y
 NISOLDIPINEZeneca

 

22.1
FDA 1st Action: 11.8(NA)
Sponsor Response: 4.3
FDA 2nd Action: 6.0(AP)

 

Y

 

 

Y
 IOPAMIDOLJohnson 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 SODIUMPharmacia

 

23.7
FDA 1st Action: 12.4(AE)
Sponsor Response: 9.0
FDA 2nd Action: 2.3(AP)

 

Y**

 

 

Y
IPRATROPIUM BROMIDEBoehringer 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
 FAMOTIDINEMerck

 

24.9
FDA 1st Action: 24.5(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.1(AP)

 

N**

 

 

Y
IPRATROPIUM BROMIDEBoehringer 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
 DIRITHROMYCINLilly

 

25.7
FDA 1st Action: 15.0(AE)
Sponsor Response: 7.0
FDA 2nd Action: 3.7(AP)

 

Y**

 

 

Y
 MOEXIPRIL HYDROCHLORIDESPKU

 

28.0
FDA 1st Action: 17.0(AE)
Sponsor Response: 9.9
FDA 2nd Action: 1.1(AP)

 

N

 

 

Y
 METRONIDAZOLESearle

 

28.6
FDA 1st Action: 12.0(AE)
Sponsor Response: 10.8
FDA 2nd Action: 5.8(AP)

 

Y**

 

 

Y
 CARVEDILOLSmithKline Beecham

 

29.5
 

 

N
NICOTINE SPRAY, METERED NASALPharmacia

 

31.6
FDA 1st Action: 15.0(AE)
Sponsor Response: 10.6
FDA 2nd Action: 6.0(AP)

 

Y**

 

 

Y
 CALCITONIN-SALMONSandoz

 

32.1
FDA 1st Action: 25.9(AE)
Sponsor Response: 1.2
FDA 2nd Action: 5.0(AP)

 

N

 

 

Y
TECHNETIUM TC-99M TETROFOSMIN KITMedi Physics

 

32.1
FDA 1st Action: 25.2(AE)
Sponsor Response: 2.3
FDA 2nd Action: 5.6(AP)

 

N

 

 

Y
 CALCIUM MUPIROCINSmithKline 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
ADAPALENEGalderma

 

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 HYDROCHLORIDEInterneuron

 

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
IOXILANCook Imaging

 

36.5
FDA 1st Action: 24.8(NA)
Sponsor Response: 5.7
FDA 2nd Action: 6.0(AP)

 

N

 

 

Y
IODIXANOLNycomed

 

36.6
FDA 1st Action: 30.1(AE)
Sponsor Response: 0.5
FDA 2nd Action: 6.0(AP)

 

N

 

 

Y
ADAPALENEGalderma

 

38.2
 

 

N
CETIRIZINE HYDROCHLORIDEPfizer

 

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)
 ATOVAQUONEBurroughs Wellcome

 

5.8
 

 

Y
 GANCICLOVIRSyntex

 

5.8
 

 

Y
 STAVUDINEBristol Myers Squibb

 

5.9
 

 

Y
 RIMEXOLONEAlcon

 

7.0
 

 

Y
 CYSTEAMINE BITARTRATEMylan

 

8.7
FDA 1st Action: 8.2(AE)
Sponsor Response: 0.4
FDA 2nd Action: 0.2(AP)

 

Y

 

 

Y
 DORZOLAMIDE HYDROCHORIDEMerck

 

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 HYDROCHLORIDESequus Pharmaceuticals

 

14.3
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.6
FDA 2nd Action: 1.7(AP)

 

Y

 

 

Y
TRETINOINRoche

 

15.9
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.6
FDA 2nd Action: 3.3(AP)

 

Y

 

 

Y
 ALPROSTADILUpJohn

 

16.7
FDA 1st Action: 11.9(NA)
Sponsor Response: 0.4
FDA 2nd Action: 4.4(AP)

 

Y

 

 

Y
 EPOPROSTENOL SODIUMBurroughs Wellcome

 

18.7
FDA 1st Action: 14.3(AE)
Sponsor Response: 2.6
FDA 2nd Action: 1.8(AP)

 

Y**

 

 

Y
DOCETAXELRhone Poulenc

 

21.6
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.2
FDA 2nd Action: 5.3(AP)

 

Y**

 

 

Y
BENTOQUATAMEnviroderm

 

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)
 SEVOFLURANEAbbott

 

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 SOLUTIONSandoz

 

11.6
 

 

Y
 CYCLOSPORINE MICROEMULSION CAPSULESSandoz

 

11.6
 

 

Y
 NALMEFENE HYDROCHLORIDEOhmeda

 

11.6
 

 

Y
 METRONIDAZOLEGalderma

 

11.7
 

 

Y
 IBUPROFEN ORAL DROPSMcNeil

 

11.8
 

 

Y
 NAPROXENSyntex

 

11.9
 

 

Y
 ACARBOSEBayer

 

12.0
 

 

Y
 ESTROGENS, CONJUGATED/MEDROXYPROGESTRONE ACETATEWyeth Ayerst Labs

 

12.0
 

 

Y
 IBUPROFEN 100 MG TABLETSMcNeil

 

12.0
 

 

Y
 MAGNESIUM SULFATEAbbott

 

12.0
 

 

Y
 TESTOSTERONE TRANSDERMALTheratech

 

12.0
 

 

Y**
 VALACYCLOVIR HCLBurroughs Wellcome

 

12.0
 

 

Y

 

BICALUTAMIDEZeneca Pharm. Group

 

12.7
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.5(AP)

 

Y

 

 

Y
 TIMOLOL HEMIHYDRATELeiras

 

13.4
FDA 1st Action: 10.4(NA)
Sponsor Response: 1.2
FDA 2nd Action: 1.9(AP)

 

Y**

 

 

Y

 

KETOPROFENBayer Cons

 

14.6
FDA 1st Action: 12.0(AE)
Sponsor Response: 2.6
FDA 2nd Action: 0.0(AP)
 
 DINOPROSTONE VAGINAL INSERTControlled Ther

 

15.0
 

 

Y**

 

GLIMEPIRIDEHoechst Roussel

 

15.0
 

 

Y**

 

 


 

 

Table 4, Continued
 

 

Generic Name

 

Sponsor

 

Approval Time (Months)

 

Review
Goal
Met

 

Total Time*

 

Resubmissions
(if necessary)
 TRAMADOL HYDROCHLORIDEJohnson RW

 

15.5
FDA 1st Action: 15.0(AE)
Sponsor Response: 0.2
FDA 2nd Action: 0.2(AP)

 

Y**

 

 

Y
 ONDANSETRON HCL DIHYDRATEGlaxo

 

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 HYDROCHLOROTHIAZIDEMerck

 

16.3
FDA 1st Action: 14.9(AE)
Sponsor Response: 1.3
FDA 2nd Action: 0.1(AP)

 

Y**

 

 

Y
 LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDEMerck

 

16.6
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.6
FDA 2nd Action: 0.1(AP)

 

Y**

 

 

Y
 LANSOPRAZOLETap Holdings

 

17.8
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.9
FDA 2nd Action: 0.9(AP)

 

Y**

 

 

Y
 AZELAIC ACIDAllergan

 

18.5
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.4
FDA 2nd Action: 6.0(AP)

 

Y

 

 

Y

 

TRANDOLAPRILKnoll Pharmaceuticals

 

18.9
FDA 1st Action: 11.9(AE)
Sponsor Response: 5.7
FDA 2nd Action: 1.3(AP)

 

Y

 

 

Y
 AMIODARONE HYDROCHLORIDEWyeth 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 HYDROCHLORIDEAkorn

 

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 SODIUMMedeva 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 SODIUMQLT

 

20.5
FDA 1st Action: 15.0(AE)
Sponsor Response: 4.8
FDA 2nd Action: 0.7(AP)

 

Y**

 

 

Y

 

NAPROXEN SODIUMElan

 

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)

 

KETOPROFENWhitehall 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

 

ESTRADIOLPharmacia and Upjohn

 

21.9
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.2
FDA 2nd Action: 5.7(AP)

 

Y**

 

 

Y
 CISAPRIDEJanssen

 

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 PHOSPHATEBristol Myers Squibb

 

22.7
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.8
FDA 2nd Action: 5.9(AP)

 

Y**

 

 

Y

 

TRIAMCINOLONE ACETONIDERhone Poulenc Rorer

 

22.7
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.7
FDA 2nd Action: 6.0(AP)

 

Y**

 

 

Y

 

DICLOFENAC SODIUMGeigy Pharmaceuticals

 

22.9
FDA 1st Action: 15.0(NA)
Sponsor Response: 2.1
FDA 2nd Action: 5.8(AP)

 

Y**

 

 

Y

 

AZITHROMYCIN DIHYDRATEPfizer

 

23.7
FDA 1st Action: 15.0(AE)
Sponsor Response: 3.2
FDA 2nd Action: 5.6(AP)

 

Y

 

 

Y

 

BUTOCONAZOLE NITRATESyntex Labs

 

24.0
FDA 1st Action: 13.5(NA)
Sponsor Response: 6.9
FDA 2nd Action: 3.6(AP)

 

Y

 

 

Y

 

IPRATROPIUM BROMIDEBoehringer 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 MONOHYDRATESchering

 

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 SULFATESchering

 

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 DIHYDRATEPfizer

 

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

 

NILUTAMIDERoussel 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

 

MEROPENEMZeneca Pharmaceutical Group

 

30.7
FDA 1st Action: 12.0(NA)
Sponsor Response: 12.8
FDA 2nd Action: 5.9(AP)

 

Y

 

 

Y

 

FERUMOXIDESAdv 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 MESYLATERoche

 

3.2
 

 

Y

 

LAMIVUDINE TABLETSGlaxo Wellcome

 

4.4
 

 

Y

 

LAMIVUDINE SOLUTION (ORAL)Glaxo Wellcome

 

4.4
 

 

Y

 

RILUZOLERhone Poulenc

 

5.5
FDA 1st Action: 4.8(AE)
Sponsor Response: 0.4
FDA 2nd Action: 0.3(AP)

 

Y

 

 

Y
 MYCOPHENOLATE MOFETILSyntex

 

5.7
 

 

Y

 

AMPHOTERICIN BLiposome

 

5.9
 

 

Y
 ALENDRONATE SODIU,Merck

 

6.0
 

 

Y

 

GANCICLOVIR STERILE INTRAVITREAL IMPLANTChiron Vision

 

7.8
 

 

Y

 

SOMATROPIN INJECTABLE 6MGSerono Laboratories

 

11.4
 

 

Y

 

LATANOPROSTPharmacia 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 POWDERUcyclyd

 

14.4
FDA 1st Action: 12.0(AE)
Sponsor Response: 2.2
FDA 2nd Action: 0.2(AP)

 

Y

 

 

Y

 

SODIUM PHENYLBUTYRATE TABLETSUcyclyd

 

14.8
FDA 1st Action: 12.0(AE)
Sponsor Response: 2.2
FDA 2nd Action: 0.7(AP)

 

Y

 

 

Y

 

GEMCITABINE HYDROCHLORIDELilly

 

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

 

IOHEXOLNycomed

 

5.5
 

 

Y

 

SELEGILINE HYDROCHLORIDESomerset Pharmaceuticals

 

8.7
 

 

Y

 

ANASTROZOLEZeneca Pharmaceuticals

 

9.0
 

 

Y

 

DOPAMINE HYDROCHLORIDE IN 5% DEXTROXE INJECTIONAbbott

 

9.4
 

 

Y

 

REMIFENTANIL HYDROCHLORIDEGlaxo Wellcome

 

9.9
 

 

Y

 

AMOXICILLIN/CLAVULANATE POTASSIUM POWDER FOR ORAL SOLUTIONSmithKline Beecham

 

10.4
 

 

Y

 

LIDOCAINE HYDROCHLORIDE/EPINEPHRINEIomed

 

10.9
 

 

Y

 

NIMBEX INJECTABLE 2 MG/ML 20 MG/MLGlaxo Wellcome

 

11.3
 

 

Y

 

ZIDOVUDINEGlaxo Wellcome

 

11.4
 

 

Y

 

OXYCODONE HYDROCHLORIDEPurdue Frederick

 

11.5
 

 

Y

 

LIDOCAINENoven Pharmaceuticals

 

11.7
 

 

Y

 

MORPHINE SULFATE CAPSULESFaulding Pharmaceuticals (US)

 

11.8
 

 

Y

 

FEXOFENADINE HYDROCHLORIDEHoechst Marion Roussel

 

11.8
 

 

Y

 

MORPHINE SULFATE INJECTABLEMallinckrodt

 

11.9
 

 

Y

 

RSV HIGH TITER FRACTION II+III PASTE (PLA)Baxter Healthcare Corp.

 

11.9
 

 

Y

 

LEUPROLIDE ACETATETap Holdings

 

12.0
 

 

Y

 

ESTROGENS CONJUGATED/MEDROXYPROGESTERONE ACETATEWyeth Ayerst Laboratories

 

12.0
 

 

Y

 

 


 

 

Table 6, Continued
 

 

Generic Name

 

Sponsor

 

Approval Time (Months)

 

Review
Goal
Met

 

Total Time*

 

Resubmissions
(if necessary)

 

LEVONORGESTRELWyeth Ayerst Laboratories

 

12.0
 

 

Y

 

SOYBEAN OILPharmacia and Upjohn

 

12.0
 

 

Y

 

BRIMONIDINE TARTRATEAllergan

 

12.0
 

 

Y

 

RISPERIDONEJanssen

 

12.3
FDA 1st Action: 11.6(AE)
Sponsor Response: 0.1
FDA 2nd Action: 0.6(AP)

 

Y

 

 

Y

 

OLANZAPINELilly

 

12.3
FDA 1st Action: 11.3(AE)
Sponsor Response: 0.6
FDA 2nd Action: 0.4(AP)

 

Y

 

 

Y

 

PROCAINAMIDE HYDROCHLORIDEParke Davis

 

13.3
FDA 1st Action: 11.7(AE)
Sponsor Response: 0.1
FDA 2nd Action: 1.4(AP)

 

Y

 

 

Y

 

VERAPAMIL HYDROCHLORIDESearle

 

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

 

IBUPROFENMcNeil Consumer Products

 

13.6
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.7
FDA 2nd Action: 0.9(AP)

 

Y

 

 

Y

 

IBUTILIDE FUMARATEPharmacia and Upjohn

 

14.0
 

 

Y**

 

RANITIDINE HYDROCHLORIDEGlaxo 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 HYDROCHLORIDEProcter and Gamble

 

14.4
FDA 1st Action: 12.0(AE)
Sponsor Response: 2.1
FDA 2nd Action: 0.3(AP)

 

Y

 

 

Y

 

FLUTICASONE PROPIONATEGlaxo Wellcome (US)

 

14.9
 

 

Y**

 

GOSERELIN ACETATEZeneca (UK)

 

14.9
 

 

Y**

 

CLEMASTINE FUMARATE/PHENYLPROPANOLAMINE HYDROCHLORIDESandoz Pharmaceuticals

 

15.0
 

 

Y**

 

HEPATITIS A VACCINE INACTIVATED (PLA)Merck & Co., Inc.

 

15.0
 

 

Y**

 

INSULIN LISPROLilly

 

15.0
 

 

Y**

 

ALBUTEROL SULFATE3M Pharmaceuticals

 

15.0
 

 

Y**

 

 


 

 

Table 6, Continued
 

 

Generic Name

 

Sponsor

 

Approval Time (Months)

 

Review
Goal
Met

 

Total Time*

 

Resubmissions
(if necessary)
ZAFIRLUKASTZeneca

 

15.0
 

 

Y**
AMOXICILLIN/CLAVULANATE POTAASIUM TABLETSSKB Pharmaceuticals

 

15.6
FDA 1st Action: 11.9(NA)
Sponsor Response: 0.4
FDA 2nd Action: 3.3(AP)

 

Y

 

 

Y
UREA, C-13Meretek

 

16.3
FDA 1st Action: 12.0(NA)
Sponsor Response: 1.7
FDA 2nd Action: 2.6(AP)

 

Y

 

 

Y
MIRTAZAPINEOrganon

 

16.5
FDA 1st Action: 11.9(AE)
Sponsor Response: 1.7
FDA 2nd Action: 2.9(AP)

 

Y

 

 

Y
NIZATIDINEWhitehall Robins

 

16.6
FDA 1st Action: 11.3(AE)
Sponsor Response: 0.7
FDA 2nd Action: 4.6(AP)

 

Y

 

 

Y
FOSPHENYTOIN SODIUMParke Davis

 

17.4
FDA 1st Action: 12.0(AE)
Sponsor Response: 1.7
FDA 2nd Action: 3.7(AP)

 

Y

 

 

Y
TERBINAFINE HYDROCHLORIDESandoz

 

17.6
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.7
FDA 2nd Action: 4.9(AP)

 

Y

 

 

Y
ROPIVACAINE HYDROCHLORIDE MONOHYDRATEAstra USA

 

17.9
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.0
FDA 2nd Action: 2.0(AP)

 

Y**

 

 

Y
CALCIPOTRIENEBristol Myers Squibb

 

18.8
FDA 1st Action: 12.0(AE)
Sponsor Response: 0.8
FDA 2nd Action: 6.0(AP)

 

Y

 

 

Y
RANITIDINE BISMUTH CITRATEGlaxo Wellcome

 

19.3
FDA 1st Action: 15.0(AE)
Sponsor Response: 2.9
FDA 2nd Action: 1.4(AP)

 

Y**

 

 

Y
ESTRADIOL FILM CONTROLLED RELEASEMenorest

 

21.5
FDA 1st Action: 12.0(AE)
Sponsor Response: 3.5
FDA 2nd Action: 6.0(AP)

 

Y

 

 

Y

 

AMMONIUM LACTATEBristol Myers

 

22.4
FDA 1st Action: 15.0(AE)
Sponsor Response: 1.4
FDA 2nd Action: 6.0(AP)

 

Y**

 

 

Y