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FY 1997 PDUFA Performance Report

TABLE OF CONTENTS

Commissioner's Report

Outcomes

Report on FY 1997 PDUFA Goals

NDAs, PLAs, And ELAs

Resubmitted NDAs, PLAs, and ELAs

Efficacy Supplements

Manufacturing Supplements

Notes

Appendices:

Appendix A: Purpose

Appendix B: PDUFA Performance Goals FY 1993- FY 1997

Appendix C: List of Approved Applications

COMMISSIONER'S REPORT

The Prescription Drug User Fee Act of 1992 is now history, but it has left a legacy of success that goes far beyond its literal intent. By working together to meet the Act's increasingly stringent performance goals, the industry and the Agency have forged a partnership that is bringing the benefits of effective new products to the market at an unprecedented pace without compromising safety.

Again this year, the Agency has exceeded all the review performance goals, but as the following pages show, the true gains are in the outcomes that matter to the health care community and patients. The five years of PDUFA have produced:

  •  More applications for new products
  •  Higher rates of approval
  •  Faster review times and total approval times

PDUFA has demonstrated that the Agency and the industry, by combining their resources and working together, can achieve the levels of performance the American people deserve. I commend everyone who has contributed to this remarkable effort.

 
Michael A. Friedman, M. D.
Lead Deputy Commissioner of Food and Drugs

 

 

 

OUTCOMES

As the original Prescription Drug User Fee Act (PDUFA) expires, the successes reported last year have been confirmed and surpassed. PDUFA has resulted in more and better applications that can be filed immediately, reviewed more quickly, and approved more quickly. New products get on the market faster, and the American consumer and the pharmacuetical industry benefit. 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, have significantly improved Agency and industry performance, predictability, and accountability.

More Applications Filed: Over the five years of PDUFA, submissions of original NDAs, PLAs, and ELAs have increased from 96 in FY 93 to 144 in FY 97. This equates to a 50 percent increase in new application workload. Over the same period, the number of efficacy supplements received each year has increased from 100 to 158 (a 58 percent increase) and manufacturing supplements have increased from 1,248 to 1,597 (up 28 percent).

Fewer Applications Refused: The "Refuse to File" rate is a key measure of submission quality. Only two of the 144 NDAs, PLAs, and ELAs submitted in FY 97 were refused. This initial Agency ruling -- the fate of more than a third of all original submissions at the start of PDUFA -- is now approaching the vanishing point. In marked contrast with the situation a few years ago, nearly all applications now go directly into the review process.

 

More Approvals on First Review: Of the NDAs and PLAs submitted in FY 96 and reviewed, 44 percent were approved on the first review. This is a major increase over initial approval rates for the previous years. Only 33 percent of the FY 95 submissions were approved on initial review, and that was an improvement over the rates of 21 percent and 28 percent for FY 94 and FY 93 submissions respectively. This high initial approval rate is another measure of submission quality and a key factor in achieving timely approvals. Over the five years of PDUFA, the median time to approval for those NDAs and PLAs that were approved on first review was 11.8 months. By contrast, those that required two or more review cycles took a median of 20.3 months to approve.

Increasing Approval Rates: Another indication of improved submission quality is the increase in the percentage of submissions that are ultimately approved. As of September 30, 1997, 65 percent of the FY 96 original NDA and PLA submissions (74) had been approved and another 13 percent (15) had received an initial "approvable" decision. The final approval rate for the FY 96 submissions should reach 85 percent. The approval rates for both the FY 95 and FY 94 submissions currently stand at 81 percent and should also reach 85 percent. For the years immediately preceding PDUFA, less than 60 percent of the original submissions were approved.1

Quicker Approval Times: The ultimate approval times for applications submitted during the PDUFA years continue to decline. If 85 percent of the FY 96 submissions are approved, the median approval time will be 12 months.2 This improves on the 15 month median of the FY 95 submissions, the 19 to 20 month medians of the FY 93 and FY 94 submissions, and the 23 month median typical of the early 1990s.1

 

REPORT ON FY 1997 PDUFA GOALS

Twenty-nine goals constitute the management framework for PDUFA (see Appendix B). Twenty-two of the goals have been reported in previous years' performance reports; seven goals remain for FY 97. Six of the FY 97 goals specify review performance targets for the submissions received subject to PDUFA during FY 97. The seventh goal relates to the FY 97 staffing level and will be addressed in the Financial Report in February 1998.

The review goals define submission categories (e.g., Efficacy Supplements), review time targets for those categories (e.g., within 12 months), and levels of achievement (e.g., 70 percent of reviews on-time). For the first four PDUFA years, both the submission categories and the review time targets remained unchanged, but the achievement levels changed, increasing from 55 percent in FY 93 to 80 percent in FY 96. For FY 97, while achievement levels continued to increase to the 90 percent level, within submission categories some of the review time targets changed.

This report updates the performance on the FY 96 submissions and evaluates the Agency's performance on the FY 97 submissions to date. Nearly all of the FY 96 submissions have been reviewed and, while some performance statistics are still open, final performance relative to the goals can now be reported. Only a preliminary performance assessment on FY 97 submissions is possible at this time. For submission categories with a 12-month review goal, it is too early to measure review performance. For those submission categories with a 6-month review goal, performance on those received in the first half of the year provides an early-indicator of final review performance.

 

 

 

Original NDAs, PLAs, and ELAs

 

 

 

Goal  -- Review and act upon complete NDAs, PLAs, and ELAs

 

FY 94-96: Within 12 months of submission date3
FY 97: Priority applications within 6 months of submission date, standard  applications within 12 months3

 

Submission Year

 

FY 94

 

FY 95

 

FY 96

 

FY 97
On-time Goal (%)

 

55

 

70

 

80

 

90

 

 

Workload -- Original submissions filed:

 

 

 

FY 93

 

FY 94

 

FY 95

 

FY 96

 

FY 974

 

 

NDAs

 

81

 

90

 

106

 

105

 

120*

 

 

PLAs+ELAs

 

7+8

 

4+4

 

12+7

 

9+6

 

16+8**

 

 

PDUFA Total

 

96

 

98

 

125

 

120

 

144

* Includes 24 priority NDAs (6-month goal)
** Includes 3 priority PLAs and 1 priority ELA (6-month goal)

Performance

 

  • FY 96 submissions:
  • Combined CDER/CBER on-time performance is currently 96 percent which exceeds FY 96 on-time goal of 80 percent
  • Could reach 100 percent if 3 pending submissions are reviewed within time frame

    FY 97 submissions:
  • As of September 30, 1997, 19 FY 97 submissions had been reviewed, all on-time
  •  Combined CDER/CBER early-indicator performance for 11 priority (6-month goal) submissions received during the first six months of FY 97 is 100 percent on-time
  • Final review performance assessment will occur on December 31, 1998

 

 

 

Resubmitted NDAs, PLAs, and ELAs

 

Goal  -- Review and act upon resubmitted5 NDAs, PLAs, and ELAs within 6 months of resubmission date:

 

Submission Year

 

FY 94

 

FY 95

 

FY 96

 

FY 97
On-time Goal

 

55

 

70

 

80

 

90

 

 

Workload -- Resubmissions received:

 

 

 

FY 93

 

FY 94

 

FY 95

 

FY 96

 

FY 97

 

 

of Original NDAs

 

2

 

24

 

58

 

89

 

85

 

 

of Original PLAs, ELAs

 

1

 

13

 

11

 

19

 

14

 

 

PDUFA Total

 

3

 

37

 

69

 

108

 

99

 

Performance

 

  • FY 96 resubmissions:
  • Combined CDER/CBER on-time performance is 99 percent which exceeds FY 96 goal of 80 percent

  • Combined CDER/CBER performance improves over FY 95 on-time rate of 96 percent

    FY 97 resubmissions:

  • As of September 30, 1997, 71 FY 97 resubmissions had been reviewed, 70 on-time
  • Combined CDER/CBER early-indicator performance for 39 resubmissions received through first 6 months is 97 percent on-time
  • Final performance assessment will occur on March 31, 1998

 

 

 

Efficacy Supplements

 

 

 

 

 

 

Goal  -- Review and act upon complete efficacy supplements to NDAs and PLAs

 

FY 94-96: Within 12 months of submission date
FY 97: Priority supplements and supplements without clinical data within 6 months of submission date, others within 12 months

 

Submission Year

 

FY 94

 

FY 95

 

FY 96

 

FY 97
On-time Goal (%)

 

55

 

70

 

80

 

90

 

 

Workload -- Efficacy supplements filed:

 

 

 

FY 93

 

FY 94

 

FY 95

 

FY 96

 

FY 974

 

 

to NDAs

 

92

 

86

 

77

 

105

 

144*

 

 

to PLAs

 

8

 

6

 

10

 

8

 

14*

 

 

PDUFA Total

 

100

 

92

 

87

 

113

 

158

* Includes 10 priority NDA supplements and 15 w/o clinical data (6-month goal)
** Includes 3 priority PLA supplements (6-month goal)

 

Performance

 

  • FY 96 Submissions:
  • Combined CDER/CBER on-time performance is 96 percent which exceeds FY 96 on-time goal of 80 percent

  • Combined CDER/CBER performance improves over FY 95 on-time rate of 93 percent

    FY 97 Submissions:

  • As of September 30, 1997, 41 FY 97 efficacy supplements had been reviewed, all on-time
  • Combined CDER/CBER early-indicator performance for 19 efficacy supplements with 6-month goals received during the first six months of FY 97 is 95 percent on-time
  • Final review performance assessment will occur on September 30, 1998

 

Manufacturing Supplements

 

 

 

Goal  -- Review and act upon complete manufacturing supplements to NDAs and PLAs

 

FY 94-96: Within 6 months of submission date
FY 97: Priority supplements and supplements without clinical data within 6 months of submission date, others within 12 months

 

Submission Year

 

FY 94

 

FY 95

 

 FY 96

 

 FY 97
On-time Goal (%)

 

55

 

70

 

80

 

90

 

 

Workload -- Manufacturing supplements filed:

 

 

 

FY 93

 

FY 94

 

FY 95

 

FY 96

 

FY 974
to NDAs

 

1,045

 

871

 

1,249

 

1,218

 

1,258*

 

 

to PLAs, ELAs

 

202

 

186

 

273

 

261

 

338**

 

 

PDUFA Total

 

1,247

 

1,057

 

1,522

 

1,479

 

1,596

* Includes 2 NDA supplements with clinical data (12 month goal)
** Includes 5 PLA/ELA supplements with clinical data (12 month goal)

 

Performance

 

  • FY 96 Submissions
  • Combined CDER/CBER on-time performance is 96 percent which exceeds FY 96 on-time goal of 80 percent
  • Proportion of submissions reviewed on-time improves over FY 95 on-time rate of 89 percent

    FY 97 Submissions
  • As of September 30, 1997, 1,039 FY 97 manufacturing supplements had been reviewed, 1,027 on-time
  • Combined CDER/CBER early-indicator performance for 806 manufacturing supplements with 6-month goals received during the first six months of FY 97 is 98 percent on-time
  • Final review performance assessment will occur on September 30, 1998

 

 

Notes:

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

2. Although  the last approvals for FY 96 submissions (as well as for earlier years) have not yet occurred, the median statistic can be computed from approvals to date and estimates of the percent of submissions that will ultimately be approved.

3.  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 the 3-month period before the original due date. This extension is not allowed for efficacy supplements, manufacturing supplements, or resubmissions.

4.  The count  o f FY 97 submissions assumes that all submissions received in the last two months of FY 97 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.

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.

APPENDIX A:   PURPOSE

The Prescription Drug User Fee Act of 1992, 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 1997.

APPENDIX B  : 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 date July 2, 1993
2. Initiate a pilot computer-assisted PLA review (CAPLAR) program during FY 93. End of FY 93 Sept. 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 94 Sept. 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 94 Sept. 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 7/2/93 Jan. 2, 1994
6. Implement project management methodology for all NDA reviews within 12 months of the initiation of user fee payments. 12 months after 7/2/93 July 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 95 Sept. 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 95 Sept. 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 95 Mar. 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 95 Mar. 31, 1996
5. Recruit and bring on board 50 percent of FDA incremental review staff by first quarter of FY 95 3 months after end of FY 94 Dec. 31, 1994
6. Implement project management methodology for all PLA/ELA reviews within 18 months of user fee payments 18 months after 7/2/93 Jan. 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 7/2/93 Jan. 2, 1995
8. Eliminate overdue backlog of NDAs within 24 months of initiation of user fees. 24 months after 7/2/93 July 2, 1995
9. Eliminate overdue backlog of PLAs, ELAs, and PLA/ELA supplements within 24 months of initiation of user fees. 24 months after 7/2/93 July 2, 1995
10. Adopt uniform computer assisted NDA standards during FY 95. End of FY 95 Sept. 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 96 Sept. 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 96 Sept. 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 96 Mar. 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 96 Mar. 31, 1997  

 

 

 

INTERIM GOALS OF FY 97    
1. Review and act upon 90 percent of complete NDA and PLA/ELA submissions for priority applications received during FY 97 within 6 months after submission date. 6 months after end of FY 97 Mar. 31, 1998
2. Review and act upon 90 percent of complete NDA and PLA/ELA submissions for standard applications received during FY 97 within 12 months after submission date. 12 months after end of FY 97 Sept. 30, 1998
3. Review and act upon 90 percent of priority supplements received during FY 97 within 6 months after submission date. 6 months after end of FY 97 Mar. 31, 1998
4. Review and act upon 90 percent of standard supplements received during FY 97 that require review of clinical data (e.g., efficacy supplements) within 12 months after submission. 12 months after end of FY 97 Sept. 30, 1998
5. Review and act upon 90 percent of supplements received during FY 97 that do not require review of clinical data (e.g., manufacturing supplements) within 6 months after submission date. 6 months after end of FY 97 Mar. 31, 1998
6. Review and act upon 90 percent of resubmitted applications received during FY 97 within 6 months after the resubmission date. 6 months after end of FY 97 Mar. 31, 1998

7. Total review staff increment recruited and on board by end of FY 97.

 

 End of FY 97 Sept. 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 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
    
-
-
-
-
-