CENTER FOR DRUG EVALUATION AND RESEARCH SPECIAL INTEREST TOPICS
TITLE: QUANTITATIVE REPORT (OFFICE OF GENERIC DRUGS, 9/96
THROUGH 7/97)
DATE: 10/1/97
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- In Septemtwr, 1991, the Oftke of Oenerie Drugs started implementation of its Application Integrity Policy by suspending review of applications suspected of being tainted by asd. Review status figures reported since W L exclude suspended applications. As of August31, 1997,0 original applications and 17 supplements were suspended. Upon completion of vslidlty assessments, SI pended applications maybe returned to active pending status. + - Note: Tentative approvsdsare coon~d as approvsdssubsequently when approved. For example 28 of the 392 approvrds for the year ending August 31, 1997 were previously st orted as tentatively approved applications.
Original ANDAs and AADAs Received
350
Actions on ANDAdAADAs
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160 =ANDfi 140 “-”’’””k--” “--’250 Wlntibioth =&Month Moving Average
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70
0rlginalANDAaL4ADAs Approved Approved or Tentatively
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ANDAs and
AADAs Pending Per Month
=>180 Oays =<180 Days IWWibmtlce
1200 1000
800
600
400 200 0
Supplements and Amendments (to Supplements) Received
1200
1400
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Supplements
WMnends. to Supps. I
1200 1000
800 600 400
200 0
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Supplements
1200
Approved
4000 =Approvals 9Cond. Approvals I 3500 3000 2500 2000 1500 1000 500 0
Supplements
Awaiting
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Days IG!K180 Days 9AADAs
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Median ANDA Review Cycle (Months) ———
16
Median ANDA Supplemental Review Time (Months)
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Percent Approved and Not-Approvable Per Month
Pwrnrd C.ambkwd Told d 100-
Percent of Submissions
With Refuse to Fiie Action
BY Month of Receipt
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office Page:
1.
of Generic 1 74-541
D~gS ANDAs Approvals —. September 16, 1997 ROXANE LABORATORIES, INC.
08/05/97
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION 300 MG (BASE)/5ML HYDROCODONE BITARTRATE ACETAMINOPHEN TABLETS, 10MG/500 MG ~ESTAZOLAM TABLETS 1 MG, AND USP
2*
40-210
PEACHTREE
PHARMACEUTICALS
08/13/97
3. 4.
74-81% 73-045
2 MG
ROYCE
LABORATORIES, USPD
~NC.
08/19/97 08/19/97
ALBUTEROL INHALATION 90 MCG/INHALATION
AEROSOL
ALPHARMA,
5.
74-023
RANTIDINE TABLETS, USP 150 MG (AS HCL), 300 MG [AS HCL) ACYCLOVIR DILTIAZEM INJECTION CAPSULES 200 MG PUREPAC GENSIA PHARMACEUTICAL LABORATORIES, CO. LTD.
08/22/97
6. 7.
74-906 74-894
08/26/97 08/26/97
HYDROCHLORIDE 5 MG/ML OINTMENT, USP
8.
74-905
FLUOCINONIDE 0.05% ACYCLOVIR INJECTION (BASE)
ALTANA,
INC.
08/26/97
9*
74-969
SODIUM FOR 500 MG (BASE),
GENSIA 1 G
LABORATORIES,
LTD.
08/26/97
10.
74-958
CLOMIPRAMINE HYDROCHLORIDE CAPSULES 25 MG, 50 MG, 75 MG ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE CAPSU 356/30/16 MG PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP 6.25 MG/10 MG PER 5 ML THIORIDAZINE HYDROCHLORIDE ORAL SOLUTION, USP (CONCENTRATE) 30 MG/ML LOPERAMIDE HYDROCHLORIDE ORAL SOLUTION 1 MG/5 ML
LEMMON
COMPANY
08/26/97
11.
40-109
MIKART,
INC.
08/26/97
12.
40-151
HI TECH INC.
PHARMACAL
COMPANY,
08/26/97
13.
40-187
PHARMACEUTICAL INC.
ASSOCIATES,
08/28/97
14.
74-730
MORTON GROVE PHARMACEUTICALS, PAR PHARMACEUTICAL,
08/28/97 INC. INC. 08/28/97
15.
74-544
usp
16. 40-220
LEUCOVORIN CALCIUM TABLETS, 5 MG (BASE), 25 MG (BASE)
METHYLPHENIDATE HYDROCHLORIDE TABLETS, MG, 10 MG, 20 MG RANITIDINE MG (BASE),
DANBURY USP 5
PHARMACAL,
INC.
08/29/97
17.
74-662
TABLETS, USP 150 300 MG (BASE)
BOEHRINGER INC.
LABORATOR~ES,
08/29/97
Office Page: 18.
of Generic 2 74-467
Drugs ANDAs Approvals September 16, 1997 TABLETS, USP 150 300 MG (BASE) TABLETS, 2 MG CAPSULES USP 0.5 GENEVA INC. PHARMACEUTICALS , 08/29/97 08/29/97 08/29/97
RANITIDINE MG (BASE), CLONAZEPAM MG , 1 MG, ETODOLAC 300 MG k
19.
74-979
EON LABS INC. GENEVA INC.
MANUFACTURING,
20.
74-840 -=
200 MG,
PHARMACEUTICALS,
Office Page:
1.
of Generic 1
D~gs AADAs Approvals September 16, 1997 USP NON-STERILE RANBAXY LIMITED RANBAXY LIMITED LABORATORIES, 08/05/97
64-105
CEFACLOR, BULK
2.
64-156
CEFACLOR CAPSULES, MG (BASE), 500 MG
USP 250 (BASE)
LABORATORIES
08/28/97
—9
*
.
Office Page: 1.
of Generic 1
Drugs ANDAs Tentative September 16, 1997 INJECTABLE
Approvals
74-704
PROPOFOL 1%
EMULSION
ABBOTT
LABORATORIES
08/06/97