Appendix B

Appendix B: Approval History of FY 93 and FY 94 Cohorts

This appendix presents the NDA and PLA approvals for the FY 93 and FY 94 cohorts. Table 1 presents the priority approvals for the FY 93 cohort; Table 2 the FY 93 standard approvals; Table 3 the FY 94 priority approvals; and Table 4 the FY 94 standard approvals.

TERMS AND CODING USED IN TABLES

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

Table 1: Priority NDA and PLA Approvals—FY 93 Cohort
(Approvals from September 1, 1992 - September 30, 1995)
Generic Name		Sponsor	Approval Time (Months)		Review Goal Met
Generic Name		Sponsor	Total Time*	Resubmissions (if necessary)	Review Goal Met
	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

**FY 93 Priority Applications: Summary Statistics for Approvals**
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

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Table 2: Standard NDA and PLA Approvals—FY 93 Cohort
(Approvals from September 1, 1992 - September 30, 1995)
Generic Name		Sponsor	Approval Time (Months)		Review Goal Met
Generic Name		Sponsor	Total Time*	Resubmissions (if necessary)	Review Goal Met
	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 IN—111 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

**FY 93 Standard Applications: Summary Statistics for Approvals**
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

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Table 3: Priority NDA and PLA Approvals—FY 94 Cohort
(Approvals from October 1, 1993 - September 30, 1995)
Generic Name		Sponsor	Approval Time (Months)		Review Goal Met
Generic Name		Sponsor	Total Time*	Resubmissions (if necessary)	Review Goal Met
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

**FY 94 Priority Applications: Summary Statistics for Approvals**
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

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Table 4: Standard NDA and PLA Approvals—FY 94 Cohort
(Approvals from October 1, 1993 - September 30, 1995)
Generic Name		Sponsor	Approval Time (Months)		Review Goal Met
Generic Name		Sponsor	Total Time*	Resubmissions (if necessary)	Review Goal Met
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

**FY 94 Standard Applications: Summary Statistics for Approvals**
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

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