This appendix updates the detailed review histories of the NDAs and PLA/BLAs submitted and approved under PDUFA. It shows approvals of all PDUFA-related submissions that took place in FY 00 as well as FY 99 approvals of FY 99 submissions. Earlier PDUFA approvals were listed in previous performance reports.
The following two tables summarize the review histories for all approved applications submitted from FY 95 through FY 99. 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.
1st Review |
2nd Review |
Total Approval Time |
||||
---|---|---|---|---|---|---|
Receipt Cohort |
N |
FDA Review |
n |
Sponsor Response |
FDA Review |
|
FY95 |
21 |
8.7 |
10 |
6.0 |
3.3 |
13.2 |
FY96 |
31 |
7.4 |
13 |
2.6 |
3.7 |
11.6 |
FY97 |
23 |
6.3 |
10 |
4.4 |
3.6 |
9.5 |
FY98 |
31 |
6.1 |
12 |
1.5 |
2.7 |
8.1 |
FY99 |
25 |
6.3 |
7 |
1.6 |
2.1 |
7.3 |
1st Review |
2nd Review |
Total Approval Time |
||||
---|---|---|---|---|---|---|
Receipt Cohort |
n |
FDA Review |
n |
Sponsor Response |
FDA Review |
|
FY95 |
83 |
12.2 |
53 |
2.8 |
4.2 |
17.8 |
FY96 |
73 |
11.9 |
40 |
4.1 |
4.1 |
17.0 |
FY97 |
80 |
11.5 |
33 |
4.4 |
3.6 |
14.8 |
FY98 |
53 |
11.3 |
29 |
3.3 |
4.5 |
16.3 |
FY99 |
46 |
10.4 |
11 |
1.0 |
2.2 |
11.2 |
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 99 can be found in the appendices of the earlier PDUFA Performance Reports which are available on FDA's web site (FDA Home)
(+) FY 99 approval of an FY 99 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AE = Approvable AP = Approved NA = Not Approvable RL = Complete Response WD = Withdrawn |
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
||
---|---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
||||
+ |
AMPRENAVIR (ORAL SOLUTION) |
Glaxo Wellcome |
4.2 |
Y |
|
SOMATROPIN - RDNA ORIGIN (SUSPENSION FOR INJECTION) |
Genentech |
5.8 |
Y |
||
+ |
CYTARABINE |
Skyepharma |
5.9 |
Y |
|
+ |
ROFECOXIB (ORAL SUSPENSION) |
Merck Res |
5.9 |
Y |
|
+ |
ROFECOXIB (tableT) |
Merck Res |
5.9 |
Y |
|
+ |
KETOTIFEN FUMARATE |
Ciba Vision |
5.9 |
Y |
|
+ |
LEVONORGEStrEL |
Womens Capital |
5.9 |
Y |
|
OSELTAMIVIR PHOSPHATE |
Roche |
6.0 |
Y |
||
LEVOBETAXOLOL HYDROCHLORIDE |
Alcon |
6.0 |
Y |
||
+ |
GANIRELIX ACETATE |
Organon Inc |
6.0 |
Y |
|
+ |
ROSIGLITAZONE MALEATE |
SKB Pharms |
6.0 |
Y |
|
+ |
PIOGLITAZONE HYDROCHLORIDE |
Takeda Pharms |
6.0 |
Y |
|
+ |
AMPRENAVIR (CAPSULE) |
Glaxo Wellcome |
6.0 |
Y |
|
+ |
PEMIROLAST POTASSIUM |
Santen |
6.0 |
Y |
|
BEXAROTENE |
Ligand |
6.2 |
FDA First Action: 6.0 (AE) |
Y Y |
|
NITRIC OXIDE |
INO |
6.91 |
FDA First Action: 5.8 (AE) |
Y Y |
|
ALOSEtrON HYDROCHLORIDE |
Glaxo Wellcome |
7.4 |
Y |
||
VERTEPORFIN |
QLT |
7.9 |
FDA First Action: 5.9 (AE) |
Y Y |
|
NEDOCROMIL SODIUM |
Allergan |
8.2 |
FDA First Action: 6.0 (AE) |
Y Y |
|
|
PNEUMOCOCCAL 7-VALENT CONJUGATE VACCINE (DIPHTHERIA CRM197 PROTEIN) (BLA) |
Lederle Laboratories Division American Cyanamid Company |
8.5 |
FDA First Action: 5.9 (RL) |
Y Y |
+ |
ZANAMIVIR |
Glaxo Wellcome |
8.9 |
Y |
|
+ |
SIROLIMUS |
Wyeth Ayerst Labs |
9.0 |
Y |
|
+ |
EPIRUBICIN HYDROCHLORIDE |
Pharmacia and Upjohn |
9.0 |
Y |
|
ASPIRIN/DIPYRIDAMOLE |
Boehringer Pharms |
11.2 |
FDA First Action: 6.0 (AE) |
Y Y |
|
ATOVAQUONE/PROGUANIL HYDROCHLORIDE |
Glaxo Wellcome |
18.5 |
FDA First Action: 6.0 (AE) |
Y Y |
Generic Name | Sponsor | Approval Time (Months) | Review Goal Met | ||
---|---|---|---|---|---|
Total Time | Resubmissions (if necessary) |
||||
QUINAPRIL HYDROCHLORIDE/ HYDROCHLOROTHIAZIDE |
Parke Davis |
7.92 |
FDA First Action: 6.9 (AE) |
Y Y |
|
C13-UREA |
Metabolic Solutions |
9.0 |
Y |
||
AZELASTINE HYDROCHLORIDE |
Asta Medica (US) |
9.6 |
Y |
||
CLOtrIMAZOLE |
Taro Pharms (US) |
9.9 |
Y |
||
SEVELAMER HYDROCHLORIDE |
Geltex |
9.9 |
Y |
||
COLESEVELAM HYDROCHLORIDE (CAPSULE) |
Sankyo Pharma Inc |
9.9 |
Y |
||
COLESEVELAM HYDROCHLORIDE (tableT) |
Sankyo Pharma Inc |
9.9 |
Y |
||
LEVETIRACETAM |
UCB Pharma |
9.9 |
Y |
||
EStrADIOL/NORGESTIMATE |
RW Johnson |
9.9 |
Y |
||
ETHINYL EStrADIOL/NORETHINDRONE ACETATE |
Parke Davis |
9.9 |
Y |
||
TENECTEPLASE (BLA) |
Genentech, Inc. |
10.0 |
Y |
||
+ |
MENOtrOPINS/LUTEINIZING HORMONE |
Ferring Pharms |
10.0 |
Y |
|
+ |
CLINDAMYCIN PHOSPHATE |
Pharmacia and Upjohn |
10.0 |
Y |
|
EXEMESTANE |
Pharmacia and Upjohn |
10.0 |
Y |
||
NAPROXEN SODIUM/PSEUDOEPHEDRINE HYDROCHLORIDE |
Bayer Cons |
10.0 |
Y |
||
GABAPENTIN |
Parke Davis |
10.0 |
Y |
||
EFLORNITHINE HYDROCHLORIDE |
Westwood Squibb |
10.0 |
Y |
||
+ |
EStrADIOL |
RW Johnson |
10.0 |
Y |
|
TESTOSTERONE |
Unimed Pharms |
10.0 |
Y |
||
LEUPROLIDE ACETATE |
Alza |
10.0 |
Y |
||
CALCIUM CHLORIDE |
Abbott Labs |
10.0 |
Y |
||
METFORMIN HYDROCHLORIDE /GLYBURIDE |
Bristol Myers Squibb |
10.0 |
Y |
||
CLARITHROMYCIN |
Abbott Labs |
10.0 |
Y |
||
NItrOGLYCERIN |
Parke Davis |
10.9 |
FDA First Action: 9.7 (AE) |
Y Y |
|
CEFAZOLIN SODIUM |
B Braun |
11.1 |
Y |
||
CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE |
AstraZeneca |
11.3 |
FDA First Action: 9.7 (AE) |
Y Y |
|
GATIFLOXACIN (tableT) |
Bristol Myers Squibb |
11.6 |
Y |
||
GATIFLOXACIN (INJECTION) |
Bristol Myers Squibb |
11.6 |
Y |
||
DILTIAZEM HYDROCHLORIDE |
Biovail Labs |
11.6 |
FDA First Action: 10.0 (AE) |
Y Y |
|
SOMAtrOPIN - RDNA ORIGIN(SOLUTION FOR INJECTION) |
Novo Nordisk Pharm |
11.7 |
Y |
||
INSULIN GLARGINE |
Aventis Pharms |
11.9 |
Y |
||
CICLOPIROX |
Aventis Pharms |
12.0 |
Y |
||
DEXMEDETOMIDINE |
Abbott Labs |
12.0 |
Y |
||
INSULIN LISPRO 25% /INSULIN LISPRO PROTAMINE 75% |
Lilly |
12.0 |
Y |
||
INSULIN LISPRO 50% /INSULIN LISPRO PROTAMINE 50% |
Lilly |
12.0 |
Y |
||
MOXIFLOXACIN HYDROCHLORIDE |
Bayer |
12.0 |
Y |
||
trETINOIN |
Johnson and Johnson |
12.0 |
Y |
||
TAZAROTENE |
Allergan |
12.0 |
Y |
||
DOXERCALCIFEROL |
Bone Care |
12.0 |
Y |
||
METHYLPHENIDATE HYDROCHLORIDE |
Alza |
12.5 |
FDA First Action: 10.0 AE) |
Y Y |
|
TINZAPARIN SODIUM |
Dupont Pharma |
12.5 |
FDA First Action: 10.0 (AE) |
Y Y |
|
OLANZAPINE |
Lilly |
13.2 |
FDA First Action: 9.7 (AE) |
Y Y |
|
CITALOPRAM HYDROBROMIDE |
Forest Labs |
13.6 |
FDA First Action: 10.0 (AE) |
Y Y |
|
MELOXICAM |
Boehringer Pharms |
15.9 |
FDA First Action: 12.0 (AE) |
Y Y |
|
SALMETEROL XINAFOATE /FLUTICASONE PROPIONATE |
Glaxo Wellcome |
17.0 |
FDA First Action: 10.1 (AE) |
Y Y |
|
RIVASTIGMINE TARtrATE (ORAL SOLUTION) |
Novartis Pharms |
17.1 |
FDA First Action: 9.6 (AE) |
Y Y |
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
|
---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
|||
BUDESONIDE (SUSPENSION FOR INHALATION) |
AstraZeneca Pharms |
26.63 |
FDA First Action: 6.0 (AE) Sponsor Response: 2.7 FDA Second Action: 6.0 (AE) Sponsor Response: 12.0 FDA Third Action: 5.9 (AP) |
Y
|
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
|
---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
|||
OXCARBAZEPINE |
Novartis Pharms |
15.6 |
FDA First Action: 12.0 (AE) Sponsor Response: 1.7 FDA Second Action: 1.9 (AP) |
Y
|
PROCHLORPERAZINE MALEATE |
SKB Pharms |
15.64 |
FDA First Action: 4.6 (NA) Sponsor Response: 2.4 FDA Second Action: 5.8 (NA) Sponsor Response: 2.5 FDA Third Action: 1.8 (AE) Sponsor Response: 1.7 FDA Fourth Action: 5.3 (AP) |
Y
|
CEVIMELINE HYDROCHLORIDE |
Snowbrand |
16.5 |
FDA First Action: 12.0 (AE) Sponsor Response: 2.5 FDA Second Action: 2.0 (AP) |
Y
|
AMINOLEVULINIC ACID HYDROCHLORIDE |
DUSA |
17.1 |
FDA First Action: 11.9 (AE) Sponsor Response: 3.3 FDA Second Action: 2.0 (AP) |
Y
|
PIPERONYL BUTOXIDE /PYRETHRINS |
Pfizer |
17.9 |
FDA First Action: 9.9 (AE) Sponsor Response: 2.0 FDA Second Action: 6.0 (AP) |
Y
|
GADOPENTETATE DIMEGLUMINE |
Berlex Labs |
18.4 |
FDA First Action: 11.9 (AE) Sponsor Response: 0.6 FDA Second Action: 1.9 (AE) Sponsor Response: 0.1 FDA Third Action: 3.9 (AP) |
Y
|
DOFETILIDE |
Pfizer |
18.8 |
FDA First Action: 11.9 (AE) Sponsor Response: 6.2 FDA Second Action: 0.7 (AP) |
Y
|
PANTOPRAZOLE SODIUM |
Wyeth Ayerst Labs |
19.1 |
FDA First Action: 12.0 (AE) Sponsor Response: 1.1 FDA Second Action: 6.0 (AP) |
Y
|
FEXOFENADINE HYDROCHLORIDE |
Aventis Pharms |
19.3 |
FDA First Action: 12.0 (AE) Sponsor Response: 1.4 FDA Second Action: 6.0 (AP) |
Y
|
SERTRALINE HYDROCHLORIDE |
Pfizer Pharms |
19.7 |
FDA First Action: 12.0 (AE) Sponsor Response: 1.7 FDA Second Action: 6.0 (AP) |
Y
|
INSULIN ASPART (RDNA ORIGIN) |
Novo Nordisk Pharm |
20.7 |
FDA First Action: 12.0 (AE) Sponsor Response: 2.7 FDA Second Action: 6.0 (AP) |
Y
|
GADOVERSETAMIDE (GLASS VIAL) |
Mallinckrodt |
21.2 |
FDA First Action: 9.7 (NA) Sponsor Response: 5.5 FDA Second Action: 6.0 (AP) |
Y
|
GADOVERSETAMIDE (PLASTIC SYRINGE) |
Mallinckrodt |
21.2 |
FDA First Action: 9.7 (NA) Sponsor Response: 5.5 FDA Second Action: 6.0 (AP) |
Y
|
GADOVERSETAMIDE (PHARMACY BULK PACK) |
Mallinckrodt |
21.2 |
FDA First Action: 9.7 (NA) Sponsor Response: 5.5 FDA Second Action: 6.0 (AP) |
Y
|
ENTACAPONE |
Orion |
21.5 |
FDA First Action: 11.9 (AE) Sponsor Response: 3.6 FDA Second Action: 6.0 (AP) |
Y
|
OXYCODONE HYDROCHLORIDE |
Roxane |
23.0 |
FDA First Action: 11.8 (AE) Sponsor Response: 5.2 FDA Second Action: 6.0 (AP) |
Y
|
MEQUINOL / trETINOIN |
Bristol Myers Squibb |
23.3 |
FDA First Action: 15.0 (AE) Sponsor Response: 7.6 FDA Second Action: 0.8 (AP) |
Y**
|
ARTICAINE HYDROCHLORIDE / EPINEPHRINE |
Deproco |
24.2 |
FDA First Action: 10.0 (AE) Sponsor Response: 1.3 FDA Second Action: 1.9 (AE) Sponsor Response: 8.9 FDA Third Action: 2.0 (AP) |
Y
|
ANTIHEMOPHILIC FACTOR (RECOMBINANT) (BLA) |
Genetics Institute, Inc. |
25.1 |
FDA First Action: 11.9 (RL) Sponsor Response: 4.2 FDA Second Action: 9.0 (AP) |
Y
N |
BECLOMETHASONE DIPROPIONATE |
3M Pharms |
28.2 |
FDA First Action: 12.0 (AE) Sponsor Response: 3.2 FDA Second Action: 6.0 (AE) Sponsor Response: 0.4 FDA Third Action: 6.5 (AP) |
Y
|
FLUTICASONE PROPIONATE |
Glaxo |
30.0 |
FDA First Action: 12.0 (AE) Sponsor Response: 2.3 FDA Second Action: 6.0 (AE) Sponsor Response: 3.7 FDA Third Action: 6.0 (AP) |
Y
|
DOCOSANOL |
Avanir |
31.1 |
FDA First Action: 12.0 (NA) Sponsor Response: 11.4 FDA Second Action: 5.9 (AE) Sponsor Response: 1.8 FDA Third Action: 0.0 (AP) |
Y
Y |
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
|
---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
|||
CHLORHEXIDINE GLUCONATE/ISOPROPYL ALCOHOL |
Medi-Flex Hospital Products |
18.05 |
FDA First Action: 12.0 (NA) Sponsor Response: 22.8 FDA Second Action: 6.0 (AP) |
Y
|
ZONISAMIDE |
Dainippon Pharm |
24.06 |
FDA First Action: 12.0 (AE) Sponsor Response: 9.4 FDA Second Action: 6.0 (AE) Sponsor Response: 3.0 FDA Third Action: 6.0 (AP) |
Y
|
BALSALAZIDE DISODIUM |
Salix |
30.87 |
FDA First Action: 11.7 (AE) Sponsor Response: 15.3 FDA Second Action: 6.0 (AE) Sponsor Response: 2.0 FDA Third Action: 1.8 (AP) |
Y
|
ADAPALENE |
Galderma Labs LP |
34.3 |
FDA First Action: 11.7 (NA) Sponsor Response: 14.0 FDA Second Action: 6.0 (AE) Sponsor Response: 0.9 FDA Third Action: 1.7 (AP) |
Y
|
ARGATROBAN |
Texas Biotech |
34.5 |
FDA First Action: 8.7 (NA) Sponsor Response: 15.3 FDA Second Action: 6.1 (AE) Sponsor Response: 2.5 FDA Third Action: 1.9 (AP) |
Y
|
RIVASTIGMINE TARtrATE (CAPSULE) |
Novartis Pharms |
36.5 |
FDA First Action: 15.0 (NA) Sponsor Response: 4.2 FDA Second Action: 6.0 (AE) Sponsor Response: 5.3 FDA Third Action: 6.0 (AP) |
Y**
|
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
|
---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
|||
MIFEPRISTONE |
Population Council |
18.08 |
FDA First Action: 6.0 (AE) Sponsor Response: 35.0 FDA Second Action: 6.0 (AE) Sponsor Response: 1.4 FDA Third Action: 6.0 (AP) |
Y
|
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
|
---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
|||
PORACTANT ALFA |
Dey Labs |
32.09 |
FDA First Action: 12.0 (NA) Sponsor Response: 8.0 FDA Second Action: 6.0 (AE) Sponsor Response: 8.5 FDA Third Action: 6.0 (AP) |
Y
|
BUDESONIDE (NASAL SPRAY) |
AstraZeneca |
38.1 |
FDA First Action: 15.0 (AE) Sponsor Response: 4.1 FDA Second Action: 6.0 (AE) Sponsor Response: 3.7 FDA Third Action: 6.0 (AE) Sponsor Response: 1.0 FDA Third Action: 2.4 (AP) |
Y**
|
TRIPTORELIN |
Debio Recherche |
47.7 |
FDA First Action: 12.0 (NA) Sponsor Response: 29.7 FDA Second Action: 6.0 (AP) |
Y
|
Generic Name |
Sponsor |
Approval Time (Months) |
Review Goal Met |
|
---|---|---|---|---|
Total Time |
Resubmissions (if necessary) |
|||
BCG Live (BLA) |
BioChem Vaccines, Inc. |
58.6 |
FDA First Action: 11.9 (NA) Sponsor Response: 3.5 FDA Second Action: 5.3 (NA) Sponsor Response: 1.6 FDA Third Action: 5.9 (NA) Sponsor Response: 3.3 FDA Fourth Action: 5.9 (RL) Sponsor Response: 15.4 FDA Fifth Action: 5.8 (AP) |
Y
Y
Y |