NEW | The list includes all cohort drug approvals through September 30, 1995; thus approvals from prior years are included. Drugs marked with NEW are those approved during FY 95. |
* | 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 time frames by 3 months |
Action Codes: NA = Not Approvable; AE = Approvable; AP = Approval |
Generic Name | Sponsor | Approval Time (Months) | Review Goal Met | ||
---|---|---|---|---|---|
Total Time* | Resubmissions (if necessary) | ||||
LEVOMETHADYL ACETATE HCL | Biodevelopment | 0.6 | Y | ||
FENTANYL CITRATE | Anesta | 4.3 | Y | ||
TACROLIMUS Injectable | Fujisawa USA | 8.1 | Y | ||
TACROLIMUS Capsules | Fujisawa USA | 8.4 | Y | ||
DORNASE ALFA (PLA) | Genentech, Inc. | 9.0 | Y | ||
IMIGLUCERASE | Genzyme | 12.1 | N | ||
APROTININ | Miles Pharmaceutical | 13.2 | 1st Action: 7.2 (AE) Sponsor Response: 5.5 2nd Action: 0.5 (AP) | Y Y | |
MENTROPIN | Organon | 14.9 | Y** | ||
NEW | METFORMIN HYDROCHLORIDE | Bristol Myers Squibb | 15.0 | Y** | |
NEW | VINORELBINE TARTRATE | Burroughs Wellcome | 15.9 | 1st Action: 14.9 (AE) Sponsor Response: 0.3 2nd Action: 0.7 (AP) | Y** Y |
FLUDEOXYGLUCOSE F-18 | Downstate Clinical | 19.0 | N | ||
RHO(D) IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (PLA) | Rh Parmaceuticals Inc. | 21.7 | 1st Action: 13.8 (NA) Sponsor Response: 1.1 2nd Action: 6.8 (AP) | N N |
Average First Review Time (n=12) | 10.6 months |
Average Sponsor Response Time (n=3) | 2.3 months |
Average Second Review Time (n=3) | 2.7 months |
Average Total Approval Time (n=12) | 11.8 months |
Generic Name | Sponsor | Approval Time (Months) | Review Goal Met | ||
---|---|---|---|---|---|
Total Time* | Resubmissions (if necessary) | ||||
DESOGESTREL/ETHINYL ESTRADIOL | Johnson RW | 2.2 | Y | ||
SOMATROPIN, BIOSYNTHETIC | Genentech, Inc. | 4.2 | Y | ||
DOBUTAMINE HYDROCHLORIDE | Baxter Healthcare | 6.9 | 1st Action: 3.2 (NA) Sponsor Response: 3.1 2nd Action: 0.6 (AP) | Y Y | |
ROCURONIUM BROMIDE | Organon | 8.6 | 1st Action: 6.4 (AE) Sponsor Response: 1.0 2nd Action: 1.2 (AP) | Y Y | |
TRIMETREXATE | U.S. Bioscience | 10.0 | Y | ||
CLOTRIMAZOLE | Miles Pharmaceutical | 10.4 | 1st Action: 7.3 (AE) Sponsor Response: 0.6 2nd Action: 2.4 (AP) | Y Y | |
TIMOLOL MALEATE | Merck | 10.9 | 1st Action: 6.5 (AE) Sponsor Response: 1.1 2nd Action: 3.3 (AP) | Y Y | |
DESMOPRESSIN ACETATE | Rhone Poulenc Rorer | 11.5 | Y | ||
FAMCICLOVIR | SmithKline Beecham | 12.0 | Y | ||
ISONIAZID/PYRAZINAMIDE/ RIFAMPIN | Marion Merrell | 12.4 | N | ||
NAPROXEN SODIUM | Hamilton | 12.8 | N | ||
BUDESONIDE | Astra | 13.5 | 1st Action: 11.5 (AE) Sponsor Response: 0.4 2nd Action: 1.5 (AP) | Y Y | |
CLARITHROMYCIN | Abbott Labs | 13.7 | Y** | ||
NEW | IBUPROFEN Chewable Tablets | McNeil | 14.4 | N | |
NEW | ESTRADIOL TRANSDERMAL SYSTEM | 3M Pharm. | 14.7 | Y** | |
GLIPIZIDE EXTENDED RELEASE | Pfizer | 15.8 | N** | ||
CLOBETASOL PROPIONATE Gel | Glaxo | 16.4 | 1st Action: 12.0 (AE) Sponsor Response: 0.7 2nd Action: 3.7 (AP) | Y Y | |
ISRADIPINE | Sandoz Pharmaceutical | 17.0 | 1st Action: 12.0 (AE) Sponsor Response: 0.2 2nd Action: 4.8 (AP) | Y Y | |
NEW | TERAZOSIN HYDROCHLORIDE | Abbott | 17.6 | 1st Action: 12.9 (AE) Sponsor Response: 0.3 2nd Action: 4.4 (AP) | N Y |
CLOBETASOL PROPIONATE Cream | Glaxo | 17.8 | 1st Action: 12.0 (AE) Sponsor Response: 0.6 2nd Action: 5.2 (AP) | Y Y | |
NEW | IBUPROFEN 200 mg capsules | Sandoz | 18.7 | N | |
NEW | FLUTICASONE PROPIONATE | Glaxo | 18.8 | 1st Action: 16.8 (AE) Sponsor Response: 1.4 2nd Action: 0.6 (AP) | N Y |
INDIUM IN111 PENTETATE | Mallinckrodt | 19.3 | N** | ||
MILRINON LACTATE | Sterling Winthrop | 19.3 | 1st Action: 3.6 (NA) Sponsor Response: 7.1 2nd Action: 1.2 (AE) Sponsor Response: 1.8 3rd Action: 5.5 (AP) | Y Y Y | |
NEW | GRANISETRON HYDROCHLORIDE | SmithKline Beecham | 19.5 | 1st Action: 7.1 (NA) Sponsor Response: 1.3 2nd Action: 5.7 (AE) Sponsor Response: 0.6 3rd Action: 4.9 (AP) | Y Y Y |
NEW | AMLODIPINE BESYLATE/ BENAZEPRIL HYDROCHLORIDE | Ciba Geigy | 20.1 | 1st Action: 13.0 (AE) Sponsor Response: 3.9 2nd Action: 3.2 (AP) | Y** Y |
MAGNESIUM SULFATE | Abbott | 20.1 | 1st Action: 6.9 (NA) Sponsor Response: 5.8 2nd Action: 7.4 (AP) | Y N | |
NEW | VARICELLA VIRUS VACCINE LIVE (PLA) | Merck & Co., Inc. | 22.0 | 1st Action: 11.5 (NA) Sponsor Response: 1.5 2nd Action: 9.0 (AP) | Y N |
NEW | ESTRADIOL | Ciba Geigy | 22.1 | 1st Action: 15.0 (AE) Sponsor Response: 5.5 2nd Action: 1.7 (AP) | Y** Y |
NEW | NISOLDIPINE | Zeneca | 22.1 | 1st Action: 11.8 (NA) Sponsor Response: 4.3 2nd Action: 6.0 (AP) | Y Y |
NEW | IOPAMIDOL | Bracco Dxs | 22.3 | 1st Action: 12.5 (NA) Sponsor Response: 3.9 2nd Action: 5.9 (AP) | N Y |
NEW | DALTEPARIN SODIUM | Pharmacia | 23.7 | 1st Action: 12.4 (AE) Sponsor Response: 9.0 2nd Action: 2.3 (AP) | Y** Y |
NEW | FAMOTIDINE | Merck | 24.9 | 1st Action: 24.5 (AE) Sponsor Response: 0.2 2nd Action: 0.1 (AP) | N** Y |
NEW | DIRITHROMYCIN | Lilly | 25.7 | 1st Action: 15.0 (AE) Sponsor Response: 7.0 2nd Action: 3.7 (AP) | Y** Y |
NEW | MOEXIPRIL HYDROCHLORIDE | SPKU | 28.0 | 1st Action: 17.0 (AE) Sponsor Response: 9.9 2nd Action: 1.1 (AP) | N Y |
NEW | METRONIDAZOLE | Searle | 28.6 | 1st Action: 12.0 (AE) Sponsor Response: 10.8 2nd Action: 5.8 (AP) | Y** Y |
NEW | CARVEDILOL | SmithKline Beecham | 29.5 | N | |
NEW | CALCITONIN-SALMON | Sandoz | 32.1 | 1st Action: 25.9 (AE) Sponsor Response: 1.2 2nd Action: 5.0 (AP) | N Y |
NEW | CALCIUM MUPIROCIN | SmithKline Beecham | 32.6 | 1st Action: 14.9 (AE) Sponsor Response: 3.8 2nd Action: 6.0 (AE) Sponsor Response: 3.1 3rd Action: 4.8 (AP) | Y** Y Y |
Average First Review Time (n=39) | 12.7 months |
Average Sponsor Response Time (n=28) | 3.2 months |
Average Second Review Time (n=25) | 3.7 months |
Average Total Approval Time (n=39) | 17.7 months |
Generic Name | Sponsor | Approval Time (Months) | Review Goal Met | ||
---|---|---|---|---|---|
Total Time* | Resubmissions (if necessary) | ||||
NEW | ATOVAQUONE | Burroughs Wellcome | 5.8 | Y | |
NEW | GANCICLOVIR | Syntex | 5.8 | Y | |
STAVUDINE | Bristol Myers Squibb | 5.9 | Y | ||
NEW | RIMEXOLONE | Alcon | 7.0 | Y | |
CYSTEAMINE BITARTRATE | Mylan | 8.7 | 1st Action: 8.2 (AE) Sponsor Response: 0.4 2nd Action: 0.2 (AP) | Y Y | |
NEW | PLAGUE VACCINE (PLA) | Greer Laboratories, Inc. | 11.5 | 1st Action: 2.3 (NA) Sponsor Response: 1.2 2nd Action: 2.9 (NA) Sponsor Response: 2.4 3rd Action: 2.7 (AP) | Y Y Y |
NEW | DORZOLAMIDE HYDROCHLORIDE | Merck | 12.0 | Y | |
NEW | ABCIXIMAB (PLA) | Centocor B. V. | 12.2 | 1st Action: 6.0 (NA) Sponsor Response: 1.7 2nd Action: 4.5 (AP) | Y Y |
NEW | ALPROSTADIL | UpJohn | 16.7 | 1st Action: 11.9 (NA) Sponsor Response: 0.4 2nd Action: 4.4 (AP) | Y Y |
NEW | EPOPROSTENOL SODIUM | Burroughs Wellcome | 18.7 | 1st Action: 14.3 (AE) Sponsor Response: 2.6 2nd Action: 1.8 (AP) | Y** Y |
Average First Review Time (n=10) | 7.9 months |
Average Sponsor Response Time (n=6) | 1.4 months |
Average Second Review Time (n=5) | 2.8 months |
Average Total Approval Time (n=10) | 10.4 months |
Generic Name | Sponsor | Approval Time (Months) | Review Goal Met | ||
---|---|---|---|---|---|
Total Time* | Resubmissions (if necessary) | ||||
NEW | SEVOFLURANE | Abbott | 10.9 | Y | |
NEW | CYCLOSPORINE MICROEMULSION Solution | Sandoz | 11.6 | Y | |
NEW | CYCLOSPORINE MICROEMULSION Capsules | Sandoz | 11.6 | Y | |
NEW | NALMEFENE HYDROCHLORIDE | Ohmeda | 11.6 | Y | |
NEW | METRONIDAZOLE TOPICAL CREAM | Galderma | 11.7 | Y | |
NEW | IBUPROFEN Oral drops | McNeil | 11.8 | Y | |
NEW | NAPROXEN | Syntex | 11.9 | Y | |
NEW | ACARBOSE | Bayer | 12.0 | Y | |
NEW | ESTROGENS, CONJ'D/ MEDROXY | Wyeth Ayerst | 12.0 | Y | |
NEW | IBUPROFEN 100 mg tablets | McNeil | 12.0 | Y | |
NEW | MAGNESIUM SULFATE IV 10 mg | Abbott | 12.0 | Y | |
NEW | TESTOSTERONE TRANSDERMAL | Theratech | 12.0 | Y** | |
NEW | VALACYCLOVIR HCL | Burroughs Wellcome | 12.0 | Y | |
NEW | TIMOLOL HEMIHYDRATE OPTHALMIC | Leiras | 13.4 | 1st Action: 10.4 (NA) Sponsor Response: 1.2 2nd Action: 1.9 (AP) | Y** Y |
NEW | DINOPROSTONE VAGINAL INSERT | Controlled Ther | 15.0 | Y** | |
NEW | TRAMADOL HYDROCHLORIDE | Johnson RW | 15.5 | 1st Action: 15.0 (AE) Sponsor Response: 0.2 2nd Action: 0.2 (AP) | Y** Y |
NEW | ONDANSETRON HCL DIHYDRATE | Glaxo | 15.8 | 1st Action: 6.6 (NA) Sponsor Response: 1.4 2nd Action: 4.9 (AE) Sponsor Response: 2.6 3rd Action: 0.4 (AP) | Y Y Y |
NEW | LOSARTAN POTASSIUM | Merck | 16.3 | 1st Action: 14.9 (AE) Sponsor Response: 1.3 2nd Action: 0.1 (AP) | Y** Y |
NEW | LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE | Merck | 16.6 | 1st Action: 15.0 (AE) Sponsor Response: 1.6 2nd Action: 0.1 (AP) | Y** Y |
NEW | LANSOPRAZOLE | Tap Holdings | 17.8 | 1st Action: 15.0 (AE) Sponsor Response: 1.9 2nd Action: 0.9 (AP) | Y** Y |
NEW | AZELAIC ACID | Allergan | 18.5 | 1st Action: 12.0 (NA) Sponsor Response: 0.4 2nd Action: 6.0 (AP) | Y Y |
NEW | AMIODARONE HYDROCHLORIDE | Wyeth Ayerst | 19.2 | 1st Action: 13.5 (AE) Sponsor Response: 0.8 2nd Action: 1.6 (AE) Sponsor Response: 0.7 3rd Action: 2.6 (AP) | Y** Y Y |
NEW | CISAPRIDE | Janssen | 22.5 | 1st Action: 9.2 (NA) Sponsor Response: 2.6 2nd Action: 7.5 (AE) Sponsor Response: 2.5 3rd Action: 0.6 (AP) | Y N Y |
Average First Review Time (n=23) | 12.2 months |
Average Sponsor Response Time (n=12) | 1.4 months |
Average Second Review Time (n=9) | 2.6 months |
Average Total Approval Time (n=23) | 14.1 months |