The following two tables summarize the review histories for all approved
applications submitted from FY 93 through FY 98. 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 shown in the tables
will increase in the future as additional applications are approved.
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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 98 can be found in the appendices of the earlier PDUFA Performance Reports which are available at http://www.fda.gov/opacom/7pdufa.html.
TERMS AND CODING USED IN TABLES
FY 98 approval of an FY 98 submission. These were not included in earlier PDUFA performance reports and are included here for completeness. | |
** | Major amendment was received within 3 months of the action due date, which extended the review timeframes by 3 months. |
Action Codes: | AE
= Approvable
AP = Approved NA = Not Approvable RL = Complete Response WD = Withdrawn |
Table 1
FY 1998 Priority NDA and BLA Submissions
Approved in FY 98 (
) and FY 99
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(if necessary) |
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EFAVIRENZ | Dupont Pharms |
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FOMIVIRSEN SODIUM | Ciba Vision |
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TRASTUZUMAB (BLA) | Genentech, Inc. |
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NEVIRAPINE | Boehringer Pharms |
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ETANERCEPT (BLA) | Immunex Corporation |
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ABACAVIR SULFATE (TABLET) | Glaxo Wellcome |
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ABACAVIR SULFATE (ORAL SOLUTION) | Glaxo Wellcome |
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OCTREOTIDE ACETATE | Novartis Pharms |
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RIBAVIRIN | Schering Plough Res |
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BASILIXIMAB (BLA) | Novartis Pharmaceutical Corporation |
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PALIVIZUMAB (BLA) | MedImmune, Inc |
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CAPECITABINE | HLR |
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RIFAPENTINE | Hoechst Marion Rssl |
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LEFLUNOMIDE | Hoechst Marion Rssl |
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BUSULFAN | Orphan Medcl |
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CELECOXIB | Searle |
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TIROFIBAN HYDROCHLORIDE .05MG/ML | Merck Res |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 0.2 | |||||
FDA Second Action: 0.3 (AP) |
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TIROFIBAN HYDROCHLORIDE .25MG/ML | Merck Res |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 0.2 | |||||
FDA Second Action: 0.3 (AP) |
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HEPATITIS B IMMUNE GLOBULIN (HUMAN) (PLA) | Nabi |
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FDA First Action: 5.6 (RL) |
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Sponsor Response: 0.2 | |||||
FDA Second Action: 1.5 (AP) |
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INFLIXIMAB (BLA) | Centocor, Inc. |
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FDA First Action: 6.0 (RL) |
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Sponsor Response: 1.2 | |||||
FDA Second Action: 0.6 (AP) |
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MIDAZOLAM HYDROCHLORIDE | Roche |
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FDA First Action: 5.9 (AE) |
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Sponsor Response: 2.0 | |||||
FDA
Second Action: 0.3 (AP)
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ALITRETINOIN | Ligand |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 0.3 | |||||
FDA Second Action: 2.0 (AP) |
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VALRUBICIN | Anthra |
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GLUCAGON | Lilly |
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LEVONORGESTREL/ ETHINYL ESTRADIOL | Gynetics |
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THYROTROPIN ALFA | Genzyme Fine |
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FDA First Action: 9.0 (AE) |
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Sponsor Response: 0.8 | |||||
FDA Second Action: 1.7 (AP) |
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TEMOZOLOMIDE | Schering |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 4.4 | |||||
FDA Second Action: 1.5 (AP) |
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TECHNETIUM TC 99M DEPREOTIDE | Diatide |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 1.8 | |||||
FDA Second Action: 5.8 (AP) |
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FERRIC SODIUM GLUCONATE | R and D Labs |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 1.7 | |||||
FDA Second Action: 6.0 (AP) |
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DENILEUKIN DIFTITOX (BLA) | Seragen, Inc. |
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FDA First Action: 6.0 (RL) |
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Sponsor Response: 1.9 | |||||
FDA Second Action: 5.9 (AP) |
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Table 2
FY 1998 Standard NDA and BLA Submissions
Approved in FY 98 (
) and FY 99
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(if necessary) |
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IOVERSOL | Mallinckrodt Medcl |
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PAROXETINE HYDROCHLORIDE (CAPSULE) | SKB Pharms |
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ESTRADIOL | Novo Nordisk |
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OXYCODONE HYDROCHLORIDE | Roxane |
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VERAPAMIL HYDROCHLORIDE | Elan Pharm |
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ITRACONAZOLE | Janssen |
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FLUOXETINE HYDROCHLORIDE | Lilly |
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METRONIDAZOLE | Galderma |
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SYNTHETIC CONJUGATED ESTROGENS | Duramed Pharms |
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SEVELAMER HYDROCHLORIDE | Geltex |
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IBUPROFEN | Whitehall Robins |
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HUMAN INSULIN | Novo Nordisk |
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OXYBUTYNIN CHLORIDE | Alza |
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CERNEVIT-12 MULTIVITAMINS | Baxter Hlthcare |
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TROVAFLOXACIN MESYLATE / AZITHROMYCIN *** | Pfizer |
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ESTRADIOL /NORETHINDRONATE ACETATE | Novo Nordisk |
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AMOXICILLIN (TABLET) | SKB Pharms |
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AMOXICILLIN (POWDER) | SKB Pharms |
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CLOTRIMAZOLE | Schering Plough |
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MICONAZOLE NITRATE | Advanced Care Prods |
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METHOXSALEN | Therakos |
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CALCITRIOL | Roche |
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MYCOPHENOLATE MOFETIL | Roche |
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RAPACURONIUM BROMIDE | Organon |
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FDA First Action: 9.9 (AE) |
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Sponsor Response: 1.9 | |||||
FDA Second Action: 2.0 (AP) |
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PAROXETINE HYDROCHLORIDE (TABLET) | SKB Pharms |
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FDA First Action: 9.7 (AE) |
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Sponsor Response: 2.4 | |||||
FDA Second Action: 1.9 (AP) |
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DOXERCALCIFEROL | Bone Care |
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LEVOBUPIVACAINE | Darwin Discovery |
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FDA First Action: 10.0 (AE) |
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Sponsor Response: 3.4 | |||||
FDA Second Action: 1.9 (AP) |
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RABEPRAZOLE SODIUM | Eisai (US) |
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FDA First Action: 10.0 (AE) |
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Sponsor Response: 1.2 | |||||
FDA Second Action: 5.5 (AP) |
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CIMETIDINE | SKB Pharms |
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FDA First Action: 11.6(AE) |
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Sponsor Response: 0.8 | |||||
FDA Second Action: 5.9 (AP) |
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RITONAVIR | Abbott Labs |
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FDA First Action: 12.0(NA) |
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Sponsor Response: 3.3 | |||||
FDA Second Action: 3.9 (AP) |
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ZALEPLON | Wyeth Ayerst Labs |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 1.8 | |||||
FDA Second Action: 5.4 (AP) |
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1 This application was withdrawn on 29-Jan-96 because of insufficient data (new patients had to be enrolled and new data submitted). It was resubmitted on 25-Nov-97. This date was used to calculate all times. The original receipt date was 27-Apr-95.
*** This application was submitted on 19-Dec-1997, approved 18-Dec-1998, and then withdrawn on 22-Sep-99.
Table 3
FY 1997 Priority NDA and BLA Submissions
Approved in FY 99
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(if necessary) |
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DALFOPRISTIN/QUINUPRISTIN | Rhone Poulenc Rorer |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 16.7 | |||||
FDA Second Action: 1.9 (AP) |
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CAFFEINE CITRATE | Opr Develop LP |
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FDA First Action: 6.0 (AE) |
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Sponsor Response: 13.0 | |||||
FDA Second Action: 6.0 (AP) |
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ORLISTAT | Roche |
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FDA First Action: 9.0 (WD) |
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Sponsor Response: 2.7 | |||||
FDA Second Action: 5.8 (AE) |
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Sponsor Response: 8.3 | |||||
FDA Third Action: 3.1 (AP) |
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2 The total approval time was adjusted because of a negative plant inspection. The time period until an acceptable inspection was received (05-Mar-98 to 26-Jul-99) was excluded from this time.
Table 4
FY 1997 Standard NDA and BLA Submissions
Approved in FY 99
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(if necessary) |
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TELMISARTAN | Boehringer Ingelheim |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 1.3 | |||||
FDA Second Action: 0.2 (AP) |
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DALFOPRISTIN/QUINUPRISTIN | Rhone Poulenc Rorer |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 10.7 | |||||
FDA Second Action: 1.9 (AP) |
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TOPIRAMATE | RW Johnson |
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FDA First Action: 11.6 (AE) |
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Sponsor Response: 1.2 | |||||
FDA Second Action: 2.0 (AP) |
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LYME DISEASE VACCINE (Recombinant OspA) (PLA) | SmithKline Beecham Biologicals |
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FDA First Action: 10.5 (RL) |
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Sponsor Response: 1.4 | |||||
FDA Second Action: 3.2 (AP) |
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GABAPENTIN | Parke Davis |
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FDA First Action: 12.0 (NA) |
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Sponsor Response: 1.4 | |||||
FDA Second Action: 1.9 (AP) |
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CILOSTAZOL | Otsuka Pharm |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 1.9 | |||||
FDA Second Action: 2.0 (AP) |
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13 C-UREA | Alimenterics |
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FDA First Action: 12.0 (NA) |
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Sponsor Response: 3.6 | |||||
FDA Second Action: 1.7 (AP) |
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INTERFERON ALFA-N1 (LYMPHOBLASTOID) (PLA) | Wellcome Foundation Limited, Wellcome Research Laboratories |
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FDA First Action: 11.9 (RL) |
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Sponsor Response: 2.0 | |||||
FDA Second Action: 2.0 (RL) |
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Sponsor Response: 0.4 | |||||
FDA Third Action: 1.5 (AP) |
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ONDANSETRON | Glaxo Wellcome |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 0.9 | |||||
FDA Second Action: 6.0 (AP) |
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LEVALBUTEROL HYDROCHLORIDE | Sepracor |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 2.8 | |||||
FDA Second Action: 6.0 (AP) |
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PROGESTERONE | Schering Plough |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 5.6 | |||||
FDA Second Action: 3.6 (AP) |
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FAMOTIDINE | Merck Res |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 2.7 | |||||
FDA Second Action: 6.0 (AE) |
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Sponsor Response: 0.4 | |||||
FDA Third Action: 1.1 (AP) |
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ANTI-THYMOCYTE GLOBULIN (RABBIT) (PLA) | Pasteur Merieux Serums et Vaccins, S.A. |
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FDA First Action: 12.0 (RL) |
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Sponsor Response: 1.3 | |||||
FDA Second Action: 4.7 (RL) |
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Sponsor Response: 0.6 | |||||
FDA Third Action: 4.8 (AP) |
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FENTANYL CITRATE | Anesta |
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FDA First Action: 12.0 (NA) |
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Sponsor Response: 5.7 | |||||
FDA Second Action: 6.0 (AP) |
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MODAFINIL | Cephalon |
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FDA First Action: 12.0 (AE) |
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Sponsor Response: 6.0 | |||||
FDA Second Action: 5.8 (AP) |
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3 The total approval time was adjusted because of a negative plant inspection. The time period until an acceptable inspection was received (04-Sep-98 to 26-Jul-99) was excluded from this time.
Table 5
FY 1996 Priority NDA and BLA Submissions
Approved in FY 99
|
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|
(if necessary) |
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COAGULATION FACTOR VIIa (Recombinant) (BLA) | Novo Nordisk A/S |
|
FDA First Action: 11.6 (NA) |
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|
Sponsor Response: 5.3 | |||||
FDA Second Action: 5.4 (RL) |
|
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Sponsor Response: 1.0 | |||||
FDA Third Action: 6.0 (RL) |
|
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Sponsor Response: 2.8 | |||||
FDA Fourth Action: 2.4 (AP) |
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|
(if necessary) |
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SIMETHICONE- CELLULOSE | Bracco DXS |
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FDA First Action: 12.0 (NA) |
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Sponsor Response: 7.0 | |||||
FDA Second Action: 6.0 (AP) |
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ANTIHEMOPHILIC FACTOR / VON WILLEBRAND FACTOR COMPLEX (HUMAN) (BLA) | Centeon Pharma GmbH |
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FDA First Action: 15.0 (NA) |
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Sponsor Response: 4.2 | |||||
FDA Second Action: 5.8 (RL) |
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Sponsor Response: 5.1 | |||||
FDA Third Action: 0.5 (AP) |
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LIDOCAINE | Teikoku Pharma USA |
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FDA First Action: 10.2 (NA) |
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Sponsor Response: 13.5 | |||||
FDA Second Action: 6.0 (AE) |
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Sponsor Response: 1.6 | |||||
FDA Third Action: 1.9 (AP) |
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POLYETHYLENE GLYCOL 3350 | Braintree Labs |
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FDA First Action: 11.9 (NA) |
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Sponsor Response: 15.3 | |||||
FDA Second Action: 6.0 (AE) |
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Sponsor Response: 0.5 | |||||
FDA Third Action: 2.0 (AP) |
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