About FDA
FY 1996 PDUFA Performance Report
TABLE OF CONTENTS
Discussion of Performance in FY 1996
Appendices:
Appendix A: PDUFA Performance Goals
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
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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. |
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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
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Review and act upon complete NDA, PLA and ELA submissions within 12 months of submission date:
FY 95 Submissions: 70 percent on-time FY 96 Submissions: 80 percent on-time Original NDAs, PLAs, and ELAs Filed:
Performance on FY 95 submissions:
Performance on FY 96 submissions:
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Goal 2
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Review and act upon efficacy supplements4 to NDAs and PLAs within 12 months of submission date:
FY 95 Submissions: 70 percent on-time FY 96 Submissions: 80 percent on-time
Efficacy Supplements Filed:
Performance on FY 95 submissions:
Performance on FY 96 submissions:
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Goal 3
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Review and act upon manufacturing supplements to NDAs, PLAs and ELAs within 6 months of submission date:
FY 95 Submissions: 70 percent on-time FY 96 Submissions: 80 percent on-time Manufacturing Supplements Filed:
Performance on FY 95 submissions:
Performance on FY 96 submissions:
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Goal 4
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Review and act upon resubmitted NDAs, PLAs and ELAs within 6 months of resubmission date:
FY 95 Submissions: 70 percent on-time FY 96 Submissions: 80 percent on-time Resubmissions Received:
Performance on FY 95 resubmissions:
Performance on FY 96 resubmissions:
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DISCUSSION OF PERFORMANCE |
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
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:
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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 |
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| 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 90 percent of complete PLAs, ELAs and NDAs for priority applications within 6 months after submission date. | 6 months after end of FY 97 | Mar. 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 97 | Sept. 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 97 | Mar. 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 97 | Sept. 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 97 | Mar. 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 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 |
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.
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| 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. | ||||||
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| Table 1 Priority NDA and PLA Approvals—FY 93 Submissions (Approvals from September 1, 1992—September 30, 1996) | |||||
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Goal Met | ||
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(if necessary) | ||||
| LEVOMETHADYL ACETATE HCL | Biodevelopment |
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| FENTANYL CITRATE | Anesta |
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| TACROLIMUS INJECTABLE | Fujisawa USA |
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| TACROLIMUS CAPSULES | Fujisawa USA |
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| DORNASE ALFA (PLA) | Genentech, INC. |
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| IMIGLUCERASE | Genzyme |
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| APROTININ | Miles Pharmaceutical |
| FDA 1st Action: 7.2(AE) Sponsor Response: 5.5 FDA 2nd Action: 0.5(AP) |
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| METFORMIN HYDROCHLORIDE | Bristol Myers Squibb |
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| VINORELBINE TARTRATE | Burroughs Wellcome |
| FDA 1st Action: 14.9(AE) Sponsor Response: 0.3 FDA 2nd Action: 0.7(AP) |
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| FLUDEOXYFLUCOSE F-18 | Downstate Clinical |
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| MILRINONE LACTATE | Sterling Winthrop |
| 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) |
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| RHO(D) IMMUNE GLOBULIN INTRAVENOUS (HUMAN)(PLA) | Rh Pharmaceuticals Inc. |
| FDA 1st Action: 13.8(NA) Sponsor Response: 1.1 FDA 2nd Action: 6.8(AP) |
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| DAUNORUBICIN CITRATE | Nexstar |
| 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) |
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| Table 2 Standard NDA and PLA Approvals—FY 93 Submissions (Approvals from September 1, 1992—September 30, 1996) | |||||
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Goal Met | ||
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(if necessary) | ||||
| DESOGESTREL/ETHINYL ESTRADIOL | Johnson RW |
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| SOMATROPIN, BIOSYNTHETIC | Genetech, Inc. |
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| DOBUTAMINE HYDROCHLORIDE | Baxter Healthcare |
| FDA 1st Action: 3.2(NA) Sponsor Response: 3.1 FDA 2nd Action: 0.6(AP) |
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| ROCURONIU, BROMIDE | Organon |
| FDA 1st Action: 6.4(AE) Sponsor Response: 1.0 FDA 2nd Action: 1.2(AP) |
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| TRIMETREXATE | U.S. Bioscience |
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| CLOTRIMAZOLE | Miles Pharmaceutical |
| FDA 1st Action: 7.3(AE) Sponsor Response: 0.6 FDA 2nd Action: 2.4(AP) |
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| TIMOLOL MALEATE | Merck |
| FDA 1st Action: 6.5(AE) Sponsor Response: 1.1 FDA 2nd Action: 3.3(AP) |
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| DESMOPRESSIN ACETATE | Rhone Poulenc Rorer |
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| FAMCICLOVIR | SmithKline Beecham |
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| ISONIAZID/PYRAZINAMIDE/RIFAMPIN | Marion Merrell |
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| NAPROXEN SODIUM | Hamilton |
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| BUDESONIDE | Astra |
| FDA 1st Action: 11.5(AE) Sponsor Response: 0.4 FDA 2nd Action: 1.5(AP) |
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| CLARITHROMYCIN | Abbott Labs |
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| IBUPROFEN CHEWABLE TABLETS | McNeil |
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| ESTRADIOL TRANSDERMAL SYSTEM | 3M Pharm. |
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| MENOTROPINS (FSH; LH) LUTEINIZING HORMONE | Organon |
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| GLIPIZIDE EXTENDED RELEASE | Pfizer |
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| Table 2, Continued | |||||
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Goal Met | ||
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(if necessary) | ||||
| CLOBETASOL PROPIONATE GEL | Glaxo |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.7 FDA 2nd Action: 3.7(AP) |
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| ISRADIPINE | Sandoz Pharmaceutical |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.2 FDA 2nd Action: 4.8(AP) |
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| TERAZOSIN HYDROCLORIDE | Abbott |
| FDA 1st Action: 12.9(AE) Sponsor Response: 0.3 FDA 2nd Action: 4.4(AP) |
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| CLOBETASOL PROPIONATE CREAM | Glaxo |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.6 FDA 2nd Action: 5.2(AP) |
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| IBUPROFEN 200 MG CAPSULES | Sandoz |
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| FLUTICASONE PROPIONATE | Glaxo |
| FDA 1st Action: 16.8(AE) Sponsor Response: 1.4 FDA 2nd Action: 0.6(AP) |
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| INDIUM IN-111 PENTETREOTIDE KIT | Mallinckrodt |
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| GRANISETRON HYDROCHLORIDE | SmithKline Beecham |
| 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) |
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| AMLODIPINE BESYLATE/BENAZEPRIL HYDROCHLORIDE | Ciba Geigy |
| FDA 1st Action: 13.0(AE) Sponsor Response: 3.9 FDA 2nd Action: 3.2(AP) |
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| MAGNESIUM SULFATE | Abbott |
| FDA 1st Action: 6.9(NA) Sponsor Response: 5.8 FDA 2nd Action: 7.4(AP) |
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| VARICELLA VIRUS VACCINE LIVE (PLA) | Merck & Co., Inc. |
| FDA 1st Action: 11.5(NA) Sponsor Response: 1.5 FDA 2nd Action: 9.0(AP) |
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| ESTRADIOL | Ciba Geigy |
| FDA 1st Action: 15.0(AE) Sponsor Response: 5.5 FDA 2nd Action: 1.7(AP) |
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| NISOLDIPINE | Zeneca |
| FDA 1st Action: 11.8(NA) Sponsor Response: 4.3 FDA 2nd Action: 6.0(AP) |
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| IOPAMIDOL | Johnson RW |
| FDA 1st Action: 12.5(NA) Sponsor Response: 3.9 FDA 2nd Action: 5.9(AP) |
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| Table 2, Continued | |||||
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Goal Met | ||
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(if necessary) | ||||
| DALTEPARIN SODIUM | Pharmacia |
| FDA 1st Action: 12.4(AE) Sponsor Response: 9.0 FDA 2nd Action: 2.3(AP) |
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| † | IPRATROPIUM BROMIDE | Boehringer Ingelheim |
| 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) |
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| FAMOTIDINE | Merck |
| FDA 1st Action: 24.5(AE) Sponsor Response: 0.2 FDA 2nd Action: 0.1(AP) |
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| † | IPRATROPIUM BROMIDE | Boehringer Ingelheim |
| 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) |
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| DIRITHROMYCIN | Lilly |
| FDA 1st Action: 15.0(AE) Sponsor Response: 7.0 FDA 2nd Action: 3.7(AP) |
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| MOEXIPRIL HYDROCHLORIDE | SPKU |
| FDA 1st Action: 17.0(AE) Sponsor Response: 9.9 FDA 2nd Action: 1.1(AP) |
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| METRONIDAZOLE | Searle |
| FDA 1st Action: 12.0(AE) Sponsor Response: 10.8 FDA 2nd Action: 5.8(AP) |
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| CARVEDILOL | SmithKline Beecham |
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| † | NICOTINE SPRAY, METERED NASAL | Pharmacia |
| FDA 1st Action: 15.0(AE) Sponsor Response: 10.6 FDA 2nd Action: 6.0(AP) |
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| CALCITONIN-SALMON | Sandoz |
| FDA 1st Action: 25.9(AE) Sponsor Response: 1.2 FDA 2nd Action: 5.0(AP) |
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| † | TECHNETIUM TC-99M TETROFOSMIN KIT | Medi Physics |
| FDA 1st Action: 25.2(AE) Sponsor Response: 2.3 FDA 2nd Action: 5.6(AP) |
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| CALCIUM MUPIROCIN | SmithKline Beecham |
| 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) |
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| † | ADAPALENE | Galderma |
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| Table 2, Continued | |||||
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Goal Met | ||
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(if necessary) | ||||
| † | RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (PLA) | Massachusetts Pulic Health Biologic Laboratories |
| 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) |
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| † | DEXFENFLURAMINE HYDROCHLORIDE | Interneuron |
| FDA 1st Action: 20.8(NA) Sponsor Response: 2.9 FDA 2nd Action: 11.5(AP) |
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| † | IMMU-4 BULK (PLA) | Charles River Division of Wilimington Partners, L.P. |
| 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) |
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| † | IOXILAN | Cook Imaging |
| FDA 1st Action: 24.8(NA) Sponsor Response: 5.7 FDA 2nd Action: 6.0(AP) |
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| † | IODIXANOL | Nycomed |
| FDA 1st Action: 30.1(AE) Sponsor Response: 0.5 FDA 2nd Action: 6.0(AP) |
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| † | ADAPALENE | Galderma |
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| † | CETIRIZINE HYDROCHLORIDE | Pfizer |
| FDA 1st Action: 32.2(AE) Sponsor Response: 6.2 FDA 2nd Action: 6.0(AP) |
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| Table 3 Priority NDA and PLA Approvals—FY 94 Submissions (Approvals from October 1, 1993—September 30, 1996) | |||||
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Goal Met | ||
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(if necessary) | ||||
| ATOVAQUONE | Burroughs Wellcome |
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| GANCICLOVIR | Syntex |
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| STAVUDINE | Bristol Myers Squibb |
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| RIMEXOLONE | Alcon |
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| CYSTEAMINE BITARTRATE | Mylan |
| FDA 1st Action: 8.2(AE) Sponsor Response: 0.4 FDA 2nd Action: 0.2(AP) |
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| DORZOLAMIDE HYDROCHORIDE | Merck |
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| ABCIXIMAB (PLA) | Centocor B.V. |
| FDA 1st Action: 6.0(NA) Sponsor Response: 1.7 FDA 2nd Action: 4.5(AP) |
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| † | DOXORUBICIN HYDROCHLORIDE | Sequus Pharmaceuticals |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.6 FDA 2nd Action: 1.7(AP) |
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| † | TRETINOIN | Roche |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.6 FDA 2nd Action: 3.3(AP) |
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| ALPROSTADIL | UpJohn |
| FDA 1st Action: 11.9(NA) Sponsor Response: 0.4 FDA 2nd Action: 4.4(AP) |
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| EPOPROSTENOL SODIUM | Burroughs Wellcome |
| FDA 1st Action: 14.3(AE) Sponsor Response: 2.6 FDA 2nd Action: 1.8(AP) |
| |
| † | DOCETAXEL | Rhone Poulenc |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.2 FDA 2nd Action: 5.3(AP) |
|
| † | BENTOQUATAM | Enviroderm |
| FDA 1st Action: 12.0(NA) Sponsor Response: 5.0 FDA 2nd Action: 6.0(AP) |
|
| Table 4 Standard NDA and PLA Approvals—FY 94 Submissions (Approvals from October 1, 1993—September 30, 1996) | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| SEVOFLURANE | Abbott |
|
| ||
| PLAGUE VACCINFE (PLA) | Greer Laboratories, Inc. |
| 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) |
| |
| CYCLOSPORINE MICROEMULSION SOLUTION | Sandoz |
|
| ||
| CYCLOSPORINE MICROEMULSION CAPSULES | Sandoz |
|
| ||
| NALMEFENE HYDROCHLORIDE | Ohmeda |
|
| ||
| METRONIDAZOLE | Galderma |
|
| ||
| IBUPROFEN ORAL DROPS | McNeil |
|
| ||
| NAPROXEN | Syntex |
|
| ||
| ACARBOSE | Bayer |
|
| ||
| ESTROGENS, CONJUGATED/MEDROXYPROGESTRONE ACETATE | Wyeth Ayerst Labs |
|
| ||
| IBUPROFEN 100 MG TABLETS | McNeil |
|
| ||
| MAGNESIUM SULFATE | Abbott |
|
| ||
| TESTOSTERONE TRANSDERMAL | Theratech |
|
| ||
| VALACYCLOVIR HCL | Burroughs Wellcome |
|
| ||
| BICALUTAMIDE | Zeneca Pharm. Group |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.2 FDA 2nd Action: 0.5(AP) |
|
| TIMOLOL HEMIHYDRATE | Leiras |
| FDA 1st Action: 10.4(NA) Sponsor Response: 1.2 FDA 2nd Action: 1.9(AP) |
| |
| KETOPROFEN | Bayer Cons |
| FDA 1st Action: 12.0(AE) Sponsor Response: 2.6 FDA 2nd Action: 0.0(AP) | |
| DINOPROSTONE VAGINAL INSERT | Controlled Ther |
|
| ||
| GLIMEPIRIDE | Hoechst Roussel |
|
| |
| Table 4, Continued | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| TRAMADOL HYDROCHLORIDE | Johnson RW |
| FDA 1st Action: 15.0(AE) Sponsor Response: 0.2 FDA 2nd Action: 0.2(AP) |
| |
| ONDANSETRON HCL DIHYDRATE | Glaxo |
| 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) |
| |
| LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE | Merck |
| FDA 1st Action: 14.9(AE) Sponsor Response: 1.3 FDA 2nd Action: 0.1(AP) |
| |
| LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE | Merck |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.6 FDA 2nd Action: 0.1(AP) |
| |
| LANSOPRAZOLE | Tap Holdings |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.9 FDA 2nd Action: 0.9(AP) |
| |
| AZELAIC ACID | Allergan |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.4 FDA 2nd Action: 6.0(AP) |
| |
| TRANDOLAPRIL | Knoll Pharmaceuticals |
| FDA 1st Action: 11.9(AE) Sponsor Response: 5.7 FDA 2nd Action: 1.3(AP) |
|
| AMIODARONE HYDROCHLORIDE | Wyeth Ayerst |
| 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) |
| |
| PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE | Akorn |
| 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) |
|
| CROMOLYN SODIUM | Medeva Pharms |
| 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) |
|
| PORFIMER SODIUM | QLT |
| FDA 1st Action: 15.0(AE) Sponsor Response: 4.8 FDA 2nd Action: 0.7(AP) |
|
| NAPROXEN SODIUM | Elan |
| FDA 1st Action: 15.0(NA) Sponsor Response: 5.0 FDA 2nd Action: 0.8(AP) |
|
| Table 4, Continued | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| KETOPROFEN | Whitehall Robins |
| 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) |
|
| ESTRADIOL | Pharmacia and Upjohn |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.2 FDA 2nd Action: 5.7(AP) |
|
| CISAPRIDE | Janssen |
| 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) |
| |
| ETOPOSIDE PHOSPHATE | Bristol Myers Squibb |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.8 FDA 2nd Action: 5.9(AP) |
|
| TRIAMCINOLONE ACETONIDE | Rhone Poulenc Rorer |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.7 FDA 2nd Action: 6.0(AP) |
|
| DICLOFENAC SODIUM | Geigy Pharmaceuticals |
| FDA 1st Action: 15.0(NA) Sponsor Response: 2.1 FDA 2nd Action: 5.8(AP) |
|
| AZITHROMYCIN DIHYDRATE | Pfizer |
| FDA 1st Action: 15.0(AE) Sponsor Response: 3.2 FDA 2nd Action: 5.6(AP) |
|
| BUTOCONAZOLE NITRATE | Syntex Labs |
| FDA 1st Action: 13.5(NA) Sponsor Response: 6.9 FDA 2nd Action: 3.6(AP) |
|
| IPRATROPIUM BROMIDE | Boehringer Ingelheim |
| 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) |
|
| BECLOMETHASONE DIPROPIONATE MONOHYDRATE | Schering |
| 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) |
|
| LORATADINE/PSEUDOEPHEDRINE SULFATE | Schering |
| FDA 1st Action: 12.0(NA) Sponsor Response: 10.3 FDA 2nd Action: 6.0(AP) |
|
| Table 4, Continued | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| NOFETUMOMAB (PLA) | Dr. Karl Thomae GmbH |
| 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) |
|
| AZITHROMYCIN DIHYDRATE | Pfizer |
| 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) |
|
| NILUTAMIDE | Roussel Uclaf |
| 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) |
|
| MEROPENEM | Zeneca Pharmaceutical Group |
| FDA 1st Action: 12.0(NA) Sponsor Response: 12.8 FDA 2nd Action: 5.9(AP) |
|
| FERUMOXIDES | Adv Magnetics |
| FDA 1st Action: 23.8(AE) Sponsor Response: 2.0 FDA 2nd Action: 4.9(AP) |
|
| Table 5 Priority NDA and PLA Approvals—FY 95 Submissions (Approvals from October 1, 1994—September 30, 1996) | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| SAQUINAVIR MESYLATE | Roche |
|
| |
| LAMIVUDINE TABLETS | Glaxo Wellcome |
|
| |
| LAMIVUDINE SOLUTION (ORAL) | Glaxo Wellcome |
|
| |
| RILUZOLE | Rhone Poulenc |
| FDA 1st Action: 4.8(AE) Sponsor Response: 0.4 FDA 2nd Action: 0.3(AP) |
|
| MYCOPHENOLATE MOFETIL | Syntex |
|
| ||
| AMPHOTERICIN B | Liposome |
|
| |
| ALENDRONATE SODIU, | Merck |
|
| ||
| GANCICLOVIR STERILE INTRAVITREAL IMPLANT | Chiron Vision |
|
| |
| SOMATROPIN INJECTABLE 6MG | Serono Laboratories |
|
| |
| LATANOPROST | Pharmacia and Upjohn |
|
| |
| INTERFERON BETA-1A (PLA) | Biogen, Inc. |
|
| |
| IMCIROMAB PENTETATE (PLA) | Centocor B.V. |
|
| |
| SODIUM PHENYLBUTYRATE POWDER | Ucyclyd |
| FDA 1st Action: 12.0(AE) Sponsor Response: 2.2 FDA 2nd Action: 0.2(AP) |
|
| SODIUM PHENYLBUTYRATE TABLETS | Ucyclyd |
| FDA 1st Action: 12.0(AE) Sponsor Response: 2.2 FDA 2nd Action: 0.7(AP) |
|
| GEMCITABINE HYDROCHLORIDE | Lilly |
| FDA 1st Action: 15.0(AE) Sponsor Response: 0.4 FDA 2nd Action: 0.1(AP) |
|
| Table 6 Standard NDA and PLA Approvals—FY 95 Submissions (Approvals from October 1, 1994—September 30, 1996) | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| CMV HIGH TITER FRACTION II+III PASTE (PLA) | Baxter Healthcare Corp. |
|
| ||
| IOHEXOL | Nycomed |
|
| |
| SELEGILINE HYDROCHLORIDE | Somerset Pharmaceuticals |
|
| |
| ANASTROZOLE | Zeneca Pharmaceuticals |
|
| |
| DOPAMINE HYDROCHLORIDE IN 5% DEXTROXE INJECTION | Abbott |
|
| |
| REMIFENTANIL HYDROCHLORIDE | Glaxo Wellcome |
|
| |
| AMOXICILLIN/CLAVULANATE POTASSIUM POWDER FOR ORAL SOLUTION | SmithKline Beecham |
|
| |
| LIDOCAINE HYDROCHLORIDE/EPINEPHRINE | Iomed |
|
| |
| NIMBEX INJECTABLE 2 MG/ML 20 MG/ML | Glaxo Wellcome |
|
| |
| ZIDOVUDINE | Glaxo Wellcome |
|
| |
| OXYCODONE HYDROCHLORIDE | Purdue Frederick |
|
| |
| LIDOCAINE | Noven Pharmaceuticals |
|
| |
| MORPHINE SULFATE CAPSULES | Faulding Pharmaceuticals (US) |
|
| |
| FEXOFENADINE HYDROCHLORIDE | Hoechst Marion Roussel |
|
| |
| MORPHINE SULFATE INJECTABLE | Mallinckrodt |
|
| |
| RSV HIGH TITER FRACTION II+III PASTE (PLA) | Baxter Healthcare Corp. |
|
| |
| LEUPROLIDE ACETATE | Tap Holdings |
|
| |
| ESTROGENS CONJUGATED/MEDROXYPROGESTERONE ACETATE | Wyeth Ayerst Laboratories |
|
| |
| Table 6, Continued | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| LEVONORGESTREL | Wyeth Ayerst Laboratories |
|
| |
| SOYBEAN OIL | Pharmacia and Upjohn |
|
| |
| BRIMONIDINE TARTRATE | Allergan |
|
| |
| RISPERIDONE | Janssen |
| FDA 1st Action: 11.6(AE) Sponsor Response: 0.1 FDA 2nd Action: 0.6(AP) |
|
| OLANZAPINE | Lilly |
| FDA 1st Action: 11.3(AE) Sponsor Response: 0.6 FDA 2nd Action: 0.4(AP) |
|
| PROCAINAMIDE HYDROCHLORIDE | Parke Davis |
| FDA 1st Action: 11.7(AE) Sponsor Response: 0.1 FDA 2nd Action: 1.4(AP) |
|
| VERAPAMIL HYDROCHLORIDE | Searle |
| FDA 1st Action: 12.0(AE) Sponsor Response: 1.1 FDA 2nd Action: 0.2(AP) |
|
| SOMATROPIN (RDNA ORIGIN) | Genentech Inc. |
| FDA 1st Action: 12.0(NA) Sponsor Response: 0.3 FDA 2nd Action: 1.2(AP) |
|
| IBUPROFEN | McNeil Consumer Products |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.7 FDA 2nd Action: 0.9(AP) |
|
| IBUTILIDE FUMARATE | Pharmacia and Upjohn |
|
| |
| RANITIDINE HYDROCHLORIDE | Glaxo Wellcome |
| FDA 1st Action: 12.2(AE) Sponsor Response: 0.3 FDA 2nd Action: 1.5(AP) |
|
| BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE | Procter and Gamble |
| FDA 1st Action: 12.0(AE) Sponsor Response: 2.1 FDA 2nd Action: 0.3(AP) |
|
| FLUTICASONE PROPIONATE | Glaxo Wellcome (US) |
|
| |
| GOSERELIN ACETATE | Zeneca (UK) |
|
| |
| CLEMASTINE FUMARATE/PHENYLPROPANOLAMINE HYDROCHLORIDE | Sandoz Pharmaceuticals |
|
| |
| HEPATITIS A VACCINE INACTIVATED (PLA) | Merck & Co., Inc. |
|
| |
| INSULIN LISPRO | Lilly |
|
| |
| ALBUTEROL SULFATE | 3M Pharmaceuticals |
|
| |
| Table 6, Continued | |||||
|
|
|
Goal Met | ||
|
(if necessary) | ||||
| † | ZAFIRLUKAST | Zeneca |
|
| |
| † | AMOXICILLIN/CLAVULANATE POTAASIUM TABLETS | SKB Pharmaceuticals |
| FDA 1st Action: 11.9(NA) Sponsor Response: 0.4 FDA 2nd Action: 3.3(AP) |
|
| † | UREA, C-13 | Meretek |
| FDA 1st Action: 12.0(NA) Sponsor Response: 1.7 FDA 2nd Action: 2.6(AP) |
|
| † | MIRTAZAPINE | Organon |
| FDA 1st Action: 11.9(AE) Sponsor Response: 1.7 FDA 2nd Action: 2.9(AP) |
|
| † | NIZATIDINE | Whitehall Robins |
| FDA 1st Action: 11.3(AE) Sponsor Response: 0.7 FDA 2nd Action: 4.6(AP) |
|
| † | FOSPHENYTOIN SODIUM | Parke Davis |
| FDA 1st Action: 12.0(AE) Sponsor Response: 1.7 FDA 2nd Action: 3.7(AP) |
|
| † | TERBINAFINE HYDROCHLORIDE | Sandoz |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.7 FDA 2nd Action: 4.9(AP) |
|
| † | ROPIVACAINE HYDROCHLORIDE MONOHYDRATE | Astra USA |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.0 FDA 2nd Action: 2.0(AP) |
|
| † | CALCIPOTRIENE | Bristol Myers Squibb |
| FDA 1st Action: 12.0(AE) Sponsor Response: 0.8 FDA 2nd Action: 6.0(AP) |
|
| † | RANITIDINE BISMUTH CITRATE | Glaxo Wellcome |
| FDA 1st Action: 15.0(AE) Sponsor Response: 2.9 FDA 2nd Action: 1.4(AP) |
|
| † | ESTRADIOL FILM CONTROLLED RELEASE | Menorest |
| FDA 1st Action: 12.0(AE) Sponsor Response: 3.5 FDA 2nd Action: 6.0(AP) |
|
| AMMONIUM LACTATE | Bristol Myers |
| FDA 1st Action: 15.0(AE) Sponsor Response: 1.4 FDA 2nd Action: 6.0(AP) |
|
