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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (6) June 1995
Center for Drug Evaluation Center for Devices and
and Research Radiological Health
*George R. Scott (301) 443-3910 Julie Stuart (301) 594-2186
Center for Biologics Center for Veterinary Medicine
Evaluation and Research
Norman Turner (301) 827-3503
Roger Eastep (301) 594-1623
*To whom general inquiries should be directed.
This report is compiled by the Division of Drug Information Resources, OM, CDER.
It is available by subscription from the National Technical Information Service,
Springfield, VA 22161.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE
NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S)
APPROVAL DATE (DOSAGE FORM) STRENGTH(S)
(CLASSIFICATION) CLASSIFICATION(S)
***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-132 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE
01-JUN-95 (TABLET) RES TRIANGLE PK, NC EQ 25MG BASE
(3 S) 27709 EQ 50MG BASE
EQ 100MG BASE*
(5-HYDROXYTRYPTAMINE 1
AGONIST)
[ACUTE TREATMENT OF
MIGRAINE ATTACKS WITH
OR WITHOUT AURA]
20-478 ULTANE ABBOTT SEVOFLURANE
07-JUN-95 (LIQUID) ABBOTT PARK, IL 100%
(1 S) 60064 (ANESTHETIC, GENERAL)
[INDUCTION AND
MAINTENANCE
OF GENERAL ANESTHESIA
IN
ADULT AND PEDIATRIC
PATIENTS
FOR INPATIENT AND
OUTPATIENT
SURGERY]
20-068 FOSCAVIR ASTRA USA FOSCARNET SODIUM
16-JUN-95 (INJECTABLE) WESTBOROUGH, MA 24MG/ML
(SUPPL-003) 01581 (NEW INDICATION --
TREATMENT OF
ACYCLOVIR-
RESISTANT HERPES IN
IMMUNOCOMPROMISED
PATIENTS)
20-516 CHILDREN'S MOTRIN MCNEIL CONS PRODS IBUPROFEN
16-JUN-95 (SUSPENSION) FORT WASHINGTON, PA 100MG/5ML
(6 S) 19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[OTC USE AS A FEVER
REDUCER AND PAIN
RELIEVER]
(OTC)
* - Not Marketed at this Time
50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL
16-JUN-95 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML
(SUPPL-003) FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML
(NEW DOSAGE REGIMEN --
FOR ACUTE OTITIS
MEDIA --
ONCE OR TWICE DAILY
DOSING)
50-688 BANAN SANKYO CEFPODOXIME PROXETIL
16-JUN-95 (GRANULE, NEW YORK, NY EQ 50MG BASE/5ML
(SUPPL-004) FOR RECONSTITUTION) 10017 EQ 100MG BASE/5ML
(NEW DOSAGE REGIMEN --
FOR ACUTE OTITIS
MEDIA --
ONCE OR TWICE DAILY
DOSING)
20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE
19-JUN-95 (TABLET) PARSIPPANY, NJ 100MG
(6 S) 07054 (HISTAMINE H2-
RECEPTOR
ANTAGONIST)
(OTC)
50-678 DYNABAC LILLY DIRITHROMYCIN
19-JUN-95 (TABLET, INDIANAPOLIS, IN 250MG
(1 S) DELAYED RELEASE) 46285 (ANTIBIOTIC,
MACROLIDE)
19-710 OPTIRAY 350 MALLINCKRODT MEDICAL IOVERSOL
21-JUN-95 (INJECTABLE) ST LOUIS, MO 74%
(SUPPL-018) 63134 (NEW INDICATION --
PERIPHERAL
ARTERIOGRAPHY)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
22-JUN-95 (CAPSULE, WAYNE, PA 20MG
(SUPPL-019) DELAYED RELEASE) 19087 (NEW INDICATION --
MAINTENANCE OF
HEALING
OF EROSIVE
ESOPHAGITIS)
20-487 VALTREX BURROUGHS WELLC VALACYCLOVIR
HYDROCHLORIDE
23-JUN-95 (TABLET) RES TRIANGLE PK, NC EQ 500MG BASE
(2 S) 27709 EQ 1GM BASE*
(ANTIVIRAL)
[TREATMENT OF HERPES
ZOSTER
(SHINGLES) IN
IMMUNOCOMPETENT
ADULTS]
* - Not Marketed at this Time
19-766 ZOCOR MERCK SIMVASTATIN
30-JUN-95 (TABLET) WEST POINT, PA 5MG
(SUPPL-011) 19486 10MG
20MG
40MG
(NEW INDICATION --
IN PATIENTS WITH
CORONARY
HEART DISEASE AND
HYPERCHOLESTEROLEMIA:
TO
REDUCE THE RISK OF
TOTAL
MORTALITY BY REDUCING
CORONARY DEATH;
REDUCE
THE RISK OF NON-FATAL
MYOCARDIAL
INFARCTION;
REDUCE THE RISK FOR
UNDERGOING MYOCARDIAL
REVASCULARIZATION
PROCEDURES; REDUCTION
OF
ELEVATED TOTAL AND
LDL
CHOLESTEROL LEVELS IN
PATIENTS WITH PRIMARY
HYPERCHOLESTEROLEMIA
[TYPES IIa AND IIb])
***ERRATA***
20-212 ZINECARD PHARMACIA DEXRAZOXANE
26-MAY-95 (INJECTABLE) COLUMBUS, OH EQ 250MG BASE/VIAL
(1 P, V*) 43216 EQ 500MG BASE/VIAL
(CARDIOPROTECTIVE)
[TO REDUCE THE
INCIDENCE
AND SEVERITY OF
CARDIOMYOPATHY
ASSOCIATED
WITH DOXORUBICIN
ADMINISTRATION IN
CERTAIN
BREAST CANCER
PATIENTS]
V* - Designated Orphan Drug
***APPROVABLE ORIGINAL NDAs***
An approvable letter indicates that FDA is prepared to approve the application
upon the satisfaction of conditions specified in the approvable letter.
Drug products which are the subject of approvable letters may not be legally
marketed until the firm has satisfied the identified deficiencies, as well as
any other requirements that may be imposed by FDA, and has been notified in
writing that the application has been approved. Further information on
approvable NDAs is not subject to Freedom of Information (FOI) release until
applications are approved.
20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE
12-JUN-95 (TABLET) PARSIPPANY, NJ 100MG
07054 (HISTAMINE H2-
RECEPTOR
ANTAGONIST)
(OTC)
20-398 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
13-JUN-95 (SUSPENSION) TITUSVILLE, NJ EQ 1MG BASE/ML
08560 EQ 2MG BASE/ML
(UPPER GI TRACT
MOTILITY
STIMULATOR)
20-393 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE
22-JUN-95 (SPRAY, METERED) RIDGEFIELD, CT 0.021MG/INH
06877 (ANTICHOLINERGIC)
[SYMPTOMATIC RELIEF
OF
RHINORRHEA ASSOCIATED
WITH ALLERGIC AND
NONALLERGIC PERENNIAL
RHINITIS]
20-394 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE
22-JUN-95 (SPRAY, METERED) RIDGEFIELD, CT 0.042MG/INH
06877 (ANTICHOLINERGIC)
[SYMPTOMATIC RELIEF
OF
RHINORRHEA ASSOCIATED
WITH
THE COMMON COLD]
***ORIGINAL ABBREVIATED NDAs***
40-084 HYDROCODONE KING PHARMS ACETAMINOPHEN
01-JUN-95 BITARTRATE BRISTOL, TN 500MG
AND ACETAMINOPHEN 37620 HYDROCODONE
BITARTRATE
(TABLET) 5MG
(ANALGESIC)
40-084 HYDROCODONE KING PHARMS ACETAMINOPHEN
01-JUN-95 BITARTRATE AND BRISTOL, TN 750MG
ACETAMINOPHEN 37620 HYDROCODONE
BITARTRATE
(TABLET) 7.5MG
(ANALGESIC)
89-718 BUTALBITAL, WEST WARD PHARM ACETAMINOPHEN
12-JUN-95 ACETAMINOPHEN EATONTOWN, NJ 325MG
AND CAFFEINE 07724 BUTALBITAL
(TABLET) 50MG
CAFFEINE
40MG
(ANALGESIC/ANXIOLYTIC)
74-204 FLUOCINONIDE NMC FLUOCINONIDE
13-JUN-95 EMULSIFIED BASE BALTIMORE, MD 0.05%
(CREAM) 21224 (CORTICOSTEROID)
64-099 AMIKACIN SULFATE SANOFI WINTHROP AMIKACIN SULFATE
20-JUN-95 (INJECTABLE) NEW YORK, NY EQ 250MG BASE/ML
[SYRINGE] 10016 (ANTIBIOTIC,
AMINOGLYCOSIDE)
74-438 GLIPIZIDE ALPHAPHARM GLIPIZIDE
20-JUN-95 (TABLET) CAROLE PARK QL D4300 5MG
AUSTRALIA 10MG
(BLOOD GLUCOSE
REGULATOR)
74-542 GLIPIZIDE INVAMED GLIPIZIDE
20-JUN-95 (TABLET) DAYTON, NJ 5MG
08810 10MG
(BLOOD GLUCOSE
REGULATOR)
40-013 LIDOCAINE HCL SANOFI WINTHROP LIDOCAINE
HYDROCHLORIDE
23-JUN-95 (INJECTABLE) NEW YORK, NY 1%
10016 (ANTIARRHYTHMIC)
40-078 LIDOCAINE HCL SANOFI WINTHROP LIDOCAINE
HYDROCHLORIDE
23-JUN-95 (INJECTABLE) NEW YORK, NY 2%
10016 (ANTIARRHYTHMIC)
73-478 LOPERAMIDE HCL LEMMON LOPERAMIDE
HYDROCHLORIDE
23-JUN-95 (SOLUTION) SELLERSVILLE, PA 1MG/5ML
18960 (ANTIDIARRHEAL)
(OTC)
74-339 CIMETIDINE MOVA CIMETIDINE
23-JUN-95 (TABLET) CAGUAS, PR 800MG
00725 (HISTAMINE H2-
RECEPTOR
ANTAGONIST)
74-340 CIMETIDINE MOVA CIMETIDINE
23-JUN-95 (TABLET) CAGUAS, PR 300MG
00725 400MG
(HISTAMINE H2-
RECEPTOR
ANTAGONIST)
74-374* PRIMSOL ASCENT TRIMETHOPRIM
HYDROCHLORIDE
23-JUN-95 (SOLUTION) BILLERICA, MA EQ 25MG BASE/5ML
01821 (ANTIBACTERIAL)
64-098 AMIKACIN SULFATE SANOFI WINTHROP AMIKACIN SULFATE
26-JUN-95 (INJECTABLE) NEW YORK, NY EQ 250MG BASE/ML
[VIAL] 10016 (ANTIBIOTIC,
AMINOGLYCOSIDE)
74-502 ISOFLURANE RHONE POULENC ISOFLURANE
27-JUN-95 (LIQUID) AVONMOUTH, 99.9%
UNITED KINGDOM (GENERAL ANESTHETIC)
* - First Time Product Available Generically
73-586 CARBIDOPA AND GENEVA PHARMS CARBIDOPA
29-JUN-95 LEVODOPA BROOMFIELD, CO 10MG
(TABLET) 80020 LEVODOPA
100MG
(ANTIPARKINSON)
73-587 CARBIDOPA AND GENEVA PHARMS CARBIDOPA
29-JUN-95 LEVODOPA BROOMFIELD, CO 25MG
(TABLET) 80020 LEVODOPA
100MG
(ANTIPARKINSON)
73-620 CARBIDOPA AND GENEVA PHARMS CARBIDOPA
29-JUN-95 LEVODOPA BROOMFIELD, CO 25MG
(TABLET) 80020 LEVODOPA
250MG
(ANTIPARKINSON)
74-250 CIMETIDINE LEK LJUBLJANA CIMETIDINE
29-JUN-95 (TABLET) LJUBLJANA, SLOVENIA 200MG
300MG
400MG
800MG
(HISTAMINE H2-
RECEPTOR
ANTAGONIST)
74-391* DICLOFENAC SODIUM ROXANE DICLOFENAC SODIUM
29-JUN-95 (TABLET, COLUMBUS, OH 25MG
DELAYED RELEASE) 43216 50MG
75MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-510 ETOPOSIDE GENSIA ETOPOSIDE
29-JUN-95 (INJECTABLE) IRVINE, CA 20MG/ML
92718 (ANTINEOPLASTIC)
* - First Time Product Available Generically
***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVAL***
A tentative approval indicates that FDA has given an abbreviated new drug
application (ANDA) or 505(b)(2) application provisional approval under the
terms of the Drug Price Competition and Patent Term Restoration Act. Such drug
products that are the subjects of tentative approvals may not be legally
marketed until the market exclusivity and/or patent term of the listed
reference drug product has expired. Final approval is also contingent upon
conditions and information available to FDA remaining acceptable. When the
application receives final approval, the product may be legally marketed. The
effective approval date will be listed in this publication and in the "Approved
Drug Products with Therapeutic Equivalence Evaluations" list published by FDA.
Additional information on these applications will become available to the
public when the applications receive final approval.
74-423 CAPTOPRIL MOVA CAPTOPRIL
07-JUN-95 (TABLET) CAGUAS, PR 12.5MG
00725 25MG
50MG
100MG
(ANGIOTENSIN
CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
17-911 CLINORIL MERCK SULINDAC
01-JUN-95 (TABLET) WEST POINT, PA 150MG
19486 200MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE
02-JUN-95 (TABLET) PALO ALTO, CA 75MG
94303 MESTRANOL
0.05MG
NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND
USAGE;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
INFORMATION FOR THE
PATIENT)
17-948* NORMINEST FE SYNTEX ETHINYL ESTRADIOL
02-JUN-95 (TABLET) PALO ALTO, CA 0.035MG
94304 FERROUS FUMARATE
75MG
NORETHINDRONE
0.5MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND
USAGE;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
INFORMATION FOR THE
PATIENT)
* - Not Marketed at This Time
18-926* NORQUEST FE SYNTEX ETHINYL ESTRADIOL
02-JUN-95 (TABLET-28 DAY) HUMACAO, PR 0.035MG
00661 FERROUS FUMARATE
75MG
NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND
USAGE;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
INFORMATION FOR THE
PATIENT)
20-301 ORTHO-CEPT JOHNSON RW DESOGESTREL
02-JUN-95 (TABLET-21 DAY) RARITAN, NJ 0.15MG
08869 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION --
STD STATEMENT;
PRECAUTIONS;
PATIENT PACKAGE
INSERT)
20-301 ORTHO-CEPT JOHNSON RW DESOGESTREL
02-JUN-95 (TABLET-28 DAY) RARITAN, NJ 0.15MG
08869 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION --
STD STATEMENT;
PRECAUTIONS;
PATIENT PACKAGE
INSERT)
20-057 CEREDASE GENZYME ALGLUCERASE
08-JUN-95 (INJECTABLE) BOSTON, MA 10 UNITS/ML
02111 80 UNITS/ML
(LABELING REVISION --
ANIMAL TOXICOLOGY)
* - Not Marketed at This Time
19-766 ZOCOR MERCK SIMVASTATIN
09-JUN-95 (TABLET) WEST POINT, PA 5MG
19486 10MG
20MG
40MG
(LABELING REVISION --
PRECAUTIONS; HOW
SUPPLIED)
19-817 IV PERSANTINE BOEHRINGER INGELHEIM DIPYRIDAMOLE
09-JUN-95 (INJECTABLE) RIDGEFIELD, CT 5MG/ML
06877 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-937 ADENOCARD MEDCO ADENOSINE
09-JUN-95 (INJECTABLE) LOS ANGELES, CA 3MG/ML
90048 (LABELING REVISION --
WARNINGS;
PRECAUTIONS)
17-010 TRIDESILON BAYER DESONIDE
12-JUN-95 (CREAM) WEST HAVEN, CT 0.05%
06516 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
17-426 TRIDESILON BAYER DESONIDE
12-JUN-95 (OINTMENT) WEST HAVEN, CT 0.05%
06516 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
19-777 ZESTRIL ZENECA LISINOPRIL
13-JUN-95 (TABLET) WILMINGTON, DE 5MG
19897 10MG
20MG
40MG
(LABELING REVISION --
DESCRIPTION;
WARNINGS)
19-888 ZESTORETIC 10-12.5 ZENECA HYDROCHLOROTHIAZIDE
13-JUN-95 (TABLET) WILMINGTON, DE 12.5MG
19897 LISINOPRIL
10MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
19-888 ZESTORETIC 20-12.5 ZENECA HYDROCHLOROTHIAZIDE
13-JUN-95 (TABLET) WILMINGTON, DE 12.5MG
19897 LISINOPRIL
20MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
19-888 ZESTORETIC 20-25 ZENECA HYDROCHLOROTHIAZIDE
13-JUN-95 (TABLET) WILMINGTON, DE 25MG
19897 LISINOPRIL
20MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
09-561 HYPAQUE NYCOMED DIATRIZOATE SODIUM
15-JUN-95 (INJECTABLE) NEW YORK, NY 25%
10016 50%
(LABELING REVISION --
BOXED WARNING)
11-386 HYPAQUE NYCOMED DIATRIZOATE SODIUM
15-JUN-95 (SOLUTION) NEW YORK, NY 40%
10016 (LABELING REVISION --
BOXED WARNING)
16-403 HYPAQUE NYCOMED DIATRIZOATE MEGLUMINE
15-JUN-95 (INJECTABLE) NEW YORK, NY 30%
10016 60%
(LABELING REVISION --
BOXED WARNING)
18-956 OMNIPAQUE 140 NYCOMED IOHEXOL
15-JUN-95 (INJECTABLE) NEW YORK, NY 30.2%
10016 (LABELING REVISION --
BOXED WARNING)
18-956 OMNIPAQUE 180 NYCOMED IOHEXOL
15-JUN-95 (SOLUTION) NEW YORK, NY 38.8%
10016 (LABELING REVISION --
BOXED WARNING)
18-956 OMNIPAQUE 210 NYCOMED IOHEXOL
15-JUN-95 (INJECTABLE) NEW YORK, NY 45.3%
10016 (LABELING REVISION --
BOXED WARNING)
18-956 OMNIPAQUE 240 NYCOMED IOHEXOL
15-JUN-95 (SOLUTION) NEW YORK, NY 51.8%
10016 (LABELING REVISION --
BOXED WARNING)
18-956 OMNIPAQUE 300 NYCOMED IOHEXOL
15-JUN-95 (SOLUTION) NEW YORK, NY 64.7%
10016 (LABELING REVISION --
BOXED WARNING)
18-956 OMNIPAQUE 350 NYCOMED IOHEXOL
15-JUN-95 (SOLUTION) NEW YORK, NY 75.5%
10016 (LABELING REVISION --
BOXED WARNING)
19-763 IFEX BRISTOL MYERS SQUIBB IFOSFAMIDE
15-JUN-95 (INJECTABLE) BUFFALO, NY 1GM/VIAL
14213 3GM/VIAL
(LABELING REVISION --
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
20-070 COGNEX PARKE DAVIS TACRINE HYDROCHLORIDE
15-JUN-95 (CAPSULE) ANN ARBOR, MI EQ 10MG BASE
48105 EQ 20MG BASE
EQ 30MG BASE
EQ 40MG BASE
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
OVERDOSAGE)
20-154 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
15-JUN-95 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
06492 50MG
100MG
150MG
(LABELING REVISION --
ADVERSE REACTIONS)
20-155 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
15-JUN-95 (POWDER WALLINGFORD, CT 100MG/PACKET
FOR RECONSTITUTION) 06492 167MG/PACKET
250MG/PACKET
(LABELING REVISION --
ADVERSE REACTIONS)
20-156 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
15-JUN-95 (POWDER WALLINGFORD, CT 10MG/ML
FOR RECONSTITUTION) 06492 (LABELING REVISION --
ADVERSE REACTIONS)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
16-JUN-95 (CAPSULE, WAYNE, PA 20MG
DELAYED RELEASE) 19087 (LABELING REVISION --
ADVERSE REACTIONS)
19-839 ZOLOFT PFIZER SERTRALINE
HYDROCHLORIDE
16-JUN-95 (TABLET) GROTON, CT EQ 50MG BASE
06340 EQ 100MG BASE
(LABELING REVISION --
PRECAUTIONS;
CONTRAINDICATIONS;
WARNINGS; ADVERSE
REACTIONS;
DOSAGE AND
ADMINISTRATION)
50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL
16-JUN-95 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML
FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML
(LABELING REVISION --
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
CLINICAL TRIALS)
50-688 BANAN SANKYO CEFPODOXIME PROXETIL
16-JUN-95 (GRANULE, NEW YORK, NY EQ 50MG BASE/5ML
FOR RECONSTITUTION) 10017 EQ 100MG BASE/5ML
(LABELING REVISION --
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
CLINICAL TRIALS)
20-057 CEREDASE GENZYME ALGLUCERASE
19-JUN-95 (INJECTABLE) BOSTON, MA 10 UNITS/ML
02111 80 UNITS/ML
(LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
19-614 VERELAN ELAN VERAPAMIL
HYDROCHLORIDE
21-JUN-95 (CAPSULE, GAINESVILLE, GA 120MG
EXTENDED RELEASE) 30504 180MG
240MG
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
PRECAUTIONS)
19-710 OPTIRAY 160 MALLINCKRODT MEDICAL IOVERSOL
21-JUN-95 (INJECTABLE) SAINT LOUIS, MO 34%
63134 (LABELING REVISION --
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-710 OPTIRAY 240 MALLINCKRODT MEDICAL IOVERSOL
21-JUN-95 (INJECTABLE) SAINT LOUIS, MO 51%
63134 (LABELING REVISION --
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-710 OPTIRAY 300 MALLINCKRODT MEDICAL IOVERSOL
21-JUN-95 (INJECTABLE) SAINT LOUIS, MO 64%
63134 (LABELING REVISION --
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-710 OPTIRAY 320 MALLINCKRODT MEDICAL IOVERSOL
21-JUN-95 (INJECTABLE) SAINT LOUIS, MO 68%
63134 (LABELING REVISION --
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-710 OPTIRAY 350 MALLINCKRODT MEDICAL IOVERSOL
21-JUN-95 (INJECTABLE) SAINT LOUIS, MO 74%
63134 (LABELING REVISION --
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
22-JUN-95 (CAPSULE, WAYNE, PA 20MG
DELAYED RELEASE) 19087 (LABELING REVISION --
CLINICAL
PHARMACOLOGY;
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-510 PEPCID MERCK FAMOTIDINE
29-JUN-95 (INJECTABLE) WEST POINT, PA 10MG/ML
19486 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-249 PEPCID MERCK FAMOTIDINE
29-JUN-95 IN PLASTIC CONTAINER WEST POINT, PA 0.4MG/ML
(INJECTABLE) 19486 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-766 ZOCOR MERCK SIMVASTATIN
30-JUN-95 (TABLET) WEST POINT, PA 5MG
19486 10MG
20MG
40MG
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1184 ATNATIV PHARMACIA AB ANTITHROMBIN III
07-JUN-95 (INJECTABLE) S-112 (HUMAN)
STOCKHOLM, SWEDEN CORPORATE ENTITY CHANGE
(A,B)
1184 KABIKINASE PHARMACIA AB STREPTOKINASE
07-JUN-95 (INJECTABLE) S-112 CORPORATE ENTITY CHANGE
STOCKHOLM, SWEDEN (A,B)
0008 NONE BAYER POSITIVE SKIN TEST
15-JUN-95 (INJECTABLE) BERKELEY, CA CONTROL-HISTAMINE
94701 (B)
1183 NONE HEALTHONE PLATELETS
20-JUN-95 (INJECTABLE) DENVER, CO (B)
80218
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950027 ID-PIPETOR MICRO TYPING SYS PIPETOR
01-JUN-95 POMPANO BEACH, FL (C)
33069
BK950006 EXTENDED HAEMONETICS EMPTY CONTAINER
09-JUN-95 STORAGE PLATELET GREENSBORO, NC COLLECT/PROCESS
COLLECTION 27409 BLOOD/COMPONENTS
SET #890F (C)
BK950015 BIOTEST DRB-SSO BIOTEST DIAGNOSTICS HLA-DRB TYPING KIT
09-JUN-95 TYPING KIT DENVILLE, NJ (C)
07834
BK950028 MTS DISPENSER MICRO TYPING SYS DISPENSER
27-JUN-95 POMPANO BEACH, FL (C)
33069
BK950007 EXTENDED HAEMONETICS EMPTY CONTAINER
28-JUN-95 STORAGE PLATELET BRAINTREE, MA COLLECT/PROCESS
COLLECTION 02184 BLOOD/COMPONENTS
SET #790F (C)
BK950008 LEUKONET HEMASURE BLOOD TRANSFUSION
28-JUN-95 PRE-STORAGE MARLBOROUGH, MA MICROFILTER
LEUKOREDUCTION 01752 (C)
FILTRATION SYSTEM
BK940028 ROUBIN INFUSION COOK INFUSION CATHETER
29-JUN-95 CATHETER BLOOMINGTON, IN (C)
47402
BK950023 CS-3000 BLOOD CELL BAXTER HLTHCARE APHERESIS KIT
29-JUN-95 SEPARATOR ROUND LAKE, IL (C)
APHERESIS KIT 60073
(C) Substantially Equivalent
***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR
TO PUBLICATION
P940031 VIGOR DR PACEMAKER CPI/GUIDANT INDICATED FOR USE IN
06/21/95 SYSTEM/VIGOR SR ST. PAUL, MN LONG-TERM CARDIAC
PACING
PACEMAKER SYSTEM 55112-5798
P950010 BOSTON SIMPLICITY POLYMER TECHNOLOGY INDICATED FOR
CLEANING,
06/09/95 WILMINGTON, MA RINSING,
DISINFECTING,
01887 AND CONDITIONING FLUORO
SILICONE ACRYLATE AND
SILICONE ACRYLATE
RIGID GAS PERMEABLE
CONTACT LENSES
***MEDICAL DEVICE - PMA SUPPLEMENTALS***
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR TO
PUBLICATION
N17755/S042 ZIMMER DOUGH-TYPE ZIMMER, INC. MANUFACTURING SITE
06/09/95 AND ZIMMER L.V.C. WARSAW, IN FOR THE POWDER
LOW VISCOSITY 46581-0708 COMPONENT AT ESSCHEM
BONE CEMENTS CO., 4000 COLUMBIA
AVENUE, LINWOOD, PA.
N18466/S016 CMW BONE CEMENT WRIGHT MEDICAL OPTIONAL PATIENT
06/21/95 TECHNOLOGY, INC. RECORD LABELLING TO
ARLINGTON, TN BE USED BY THE
38002 HOSPITAL IN RECORDING
THE USE OF CMW BONE
CEMENT
P790017/S056 VARIOUS USCI C.R. BARD, INC. REVISED LABELING;
06/12/95 BALLOON BILLERICA, MA APPROVAL BASED ON
DILATATION CATHETERS 01821 EXEMPTION FROM
APPLICATION
INTEGRITY POLICY
P800022/S023 ZYPLAST COLLAGEN COLLAGEN CORPORATION REVISIONS IN THE
06/16/95 IMPLANT & ZYDERM PALO ALTO, CA PHYSICIAN PACKAGE
INSERTS
COLLAGEN IMPLANT 94303
P810046/S154 ACS RX LIFESTREAM ADVANCED NEW MODEL
06/14/95 CORONARY DILATATION CARDIOVASCULAR SYSTEMS ACS RX LIFESTREAM
CATHETER W/10MM, SANTA CLARA, CA CORONARY DILATATION
QUARTER-SIZE/20MM 95052-8167 CATHETER W/10MM,
AND 30MM LENGTHS DILATATION
QUARTER-SIZE/20MM
AND 30MM LENGTHS
P810046/S155 ACS CORONARY ADVANCED REVISED LABELING
06/07/95 BALLOON DILATATION CARDIOVASCULAR SYSTEMS FOR ALL ACS
CATHETERS SANTA CLARA, CA CORONARY BALLOON
95052-8167 DILATATION CATHETERS
P820021/S027 FOCUS TORIC CIBA VISION CORPORATION REVISED LABELING TO
06/28/95 (VIFILCON A) DULUTH, GA INCORPORATE MONOVISION
SOFT (HYDROPHILIC) 30136-1518 FITTING INFORMATION
INTO
CONTACT LENSES THE PRACTITIONER
FITTING
GUIDE FOR PLANNED
REPLACEMENT
P820049/S059 PS-100A, 101A, 102A, ALLERGAN MEDICAL OPTICS, INC. ALTERNATE
06/01/95 103A, 104A, 106A, IRVINE, CA MANUFACTURING PROCESS
107A, 108A, 109A, 92718 AND ASSOCIATED
110A, 111A, LABELING CLAIMS
& PA-105A
DURALENS ULTRAVIOLET-
ABSORBING PMMA
POSTERIOR CHAMBER
INTRAOCULAR LENSES
(IOLS)
P820083/S020 GORE-TEX EPTFE W.L. GORE & ASSOCIATES, INC. STEAM
STERILIZATION
06/05/95 SUTURES FLAGSTAFF, AZ AN ALTERNATE
86003-2300 STERILIZATION
METHOD
TO ETHYLENE OXIDE
(ETO)
P830033/S026 MODELS PCUB-30SEO SURGIDEV CORPORATION NEW MODELS: PCUB-30SEO
&
06/05/95 & PCUB-32SEO GOLETA, CA PCUB-32SEO
ULTRAVIOLET- 93117 ULTRAVIOLET-
ABSORBING ABSORBING
POSTERIOR CHAMBER POSTERIOR CHAMBER
INTRAOCULAR LENSES INTRAOCULAR LENSES
P840068/S024 DELTA MODELS CARDIAC ALTERNATE METHOD
06/05/95 936, 937, & 938 - PACEMAKERS, INC. FOR BURN-IN OF THE
VISTA MODELS 443, ST. PAUL, MN BATTERIES
444, 445, 446, 447, 55112-5798
448, 449,
940, & 941 -
VIGOR MODELS 460,
465, 950, & 955
PACEMAKERS
P850021/S031 AMERICAN EDWARDS BAXTER HEALTHCARE REVISED LABELING
06/12/95 LABORATORIES HYBRID CORPORATION FOR: SLINKY, INTREPID,
PERCUTANEOUS SANTA ANA, CA REACH 14, LONG REACH
TRANSLUMINAL 92711-1150 30MM & 40MM, READY 14,
CORONARY ANGIOPLASTY DISTANCE 14,
(PTCA) CATHETERS LONG DISTANCE 30 &
40MM, &
GRAFT DISTANCE PTCA
CATHETERS
P860004/S033 MEDTRONIC SYNCHROMED MEDTRONIC NEUROLOGICAL ADDITIONAL WARNING
06/05/95 INFUSION SYSTEM MINNEAPOLIS, MN STATEMENTS ADDED TO
55440-9087 THE SYNCHROMED
INFUSION SYSTEM
TECHNICAL MANUALS
P860022/S046 BOSTON EQUALENS POLYMER TECHNOLOGY LABELING REVISIONS
06/05/95 RIGID GAS PERMEABLE CORPORATION MADE TO STRENGTHEN
CONTACT LENSES WILMINGTON, MA THE WARNINGS &
01887 PRECAUTIONS FOR DAILY
& EXTENDED WEAR
P860022/S047 BOSTON EQUALENS II POLYMER TECHNOLOGY LABELING REVISIONS
06/05/95 RIGID GAS PERMEABLE CORPORATION MADE TO STRENGTHEN
CONTACT LENSES WILMINGTON, MA THE WARNINGS &
01887 PRECAUTIONS FOR DAILY
AND EXTENDED WEAR
P860047/S009 OCUCOAT STORZ OPHTHALMICS, INC. CHANGE IN TRADE
06/09/95 (2% HYDROXYPROPYL- CLEARWATER, FL NAME FROM OCCUCOAT
METHYLCELLULOSE 34619 TO OCUCOAT
SOLUTION)
P880003/S042 SLEEK CORDIS CORPORATION REVISED LABELING
06/05/95 PTCA DILATATION MIAMI, FL
CATHETERS W/3CM 33102-5700
& 4CM BALLOONS
P880003/S043 PREDATOR PTCA CORDIS CORPORATION REVISED LABELING
06/05/95 DILATATION CATHETER MIAMI, FL
33102-5700
P880003/S044 PREDATOR CORDIS CORPORATION REVISED LABELING
06/05/95 PTCA DILATATION MIAMI, FL
CATHETERS W/3CM 33102-5700
& 4CM BALLOONS
P880003/S045 TRAKSTAR 14 CORDIS CORPORATION REVISED LABELING
06/05/95 PTCA DILATATION MIAMI, FL
CATHETERS 33102-5700
P880027/S034 SHORTGOOSE SCHNEIDER (USA), INC. ADDITION OF SHORTENED
06/05/95 NONCOMPLIANT MINNEAPOLIS, MN BALLOON LENGTHS TO
PTCA CATHETERS 55442 THE MONGGOOSE PTCA
CATHETER MARKETED
UNDER NEW TRADE NAME
SCHNEIDER SHORTGOOSE
NONCOMPLIANT PTCA
CATHETER
P880086/S028 TRILOGY SIEMENS PACESETTER, INC. NEW MODELS
06/07/95 MODELS:235OL DR, SYLMAR, CA
2308L DC, 225OL SR, 91392-9221
PULSE GENERATORS
P880086/S031 SYNCHRONY III & PACESETTER, INC. LABELING CHANGE TO
06/21/95 PARAGON III SYLMAR, CA ADDRESS POTENTIAL FOR
PULSE GENERATOR 91392-9221 CROSSTALK
FAMILIES
P880098/S008 MENICON SF-P MENICON, INC. MODIFY LABELING FOR
06/23/95 (MELAFOCON A) WASHINGTON, D.C. THE PURPOSE OF ADDING
RIGID GAS PERMEABLE 20005 OR STRENGTHENING THE
CONTACT LENS FOR WARNING AND
DAILY & PRECAUTIONS
EXTENDED WEAR
P890034/S004 MODEL APT 1010 INFRASONICS, INC. REVISED SECONDARY
06/14/95 ULTRAHIGH ROCKY HILL, CT FLOW SYSTEM, REMOVAL
FREQUENCY 06067-3440 OF ALARMS, INCLUSION
VENTILATOR OF CLINICAL
ASSISTANCE NOMOGRAM
ON DISPLAY SCREEN,
PRE-OPERATIONAL TEST
DISPLAY SCREEN
P890043/S030 SIMPSON CORONARY DEVICES FOR VASCULAR ADD SMALL PEBAX
06/12/95 ATHEROCATH, INTERVENTION, INC. INSERT INSIDE BALLOON
ATHEROCATH-GTO REDWOOD CITY, CA LEG PRIOR TO
WITH MULTI-LAY 94063 LAMINATION, USE OF
NOSECONE, TECOFLEX 85A, MODIFY
ATHEROCATH-GTO, TORQUE CABLE CHANGES
ATHERCATH-GTO "THE DRIVESHAFT TO
GRAFT AND LARGE FILLET" DIMENSION
GRAFT SIZES
P890048/S004 USCI PROBE III C.R. BARD, INC. REVISED LABELING;
06/14/95 BALLOON-ON-A-WIRE BILLERICA, MA APPROVAL BASED ON
DILATATION SYSTEM 01821 EXEMPTION FROM
APPLICATION INTEGRITY
POLICY
P890057/S004 MODEL 3100, 3100A SENSORMEDICS AUTHORIZATION OF
06/12/95 HIGH FREQUENCY CORPORATION SENSORMEDICS CORP AS
OSCILLATORY YORBA LINDA, CA ALTERNATIVE
VENTILATOR 92687 MANUFACTURING SITE FOR
2 PATIENT CIRCUIT
ASSEMBLIES & A
BELLOWS/
WATER TRAP ASSEMBLY, &
A CAP/DIAPHRAGM
P890063/S004 THE GENESIS HOME CARELINK CORPORATION FIRMWARE CHANGES TO
06/16/95 UTERINE ACTIVITY SANTA ANA, CA INCREASE RELIABILITY
MONITORING SYSTEM 92705 AND BUILT-IN SYSTEM
DIAGNOSTICS
P900023/S015 ABIOMED BVS 5000 ABIOMED, INC. CHANGE IN THE
06/22/95 BI-VENTRICULAR DANVERS, MA STERILIZATION CYCLE
SUPPORT SYSTEM 01923
P900061/S009 MEDTRONIC MEDTRONIC, INC. NEW MODEL: BEAD-
06/23/95 MODEL 7220 B/D/E MINNEAPOLIS, MN BLASTED FINISH WITH
JEWEL PLUS ARRHYTHMIA 55432-3576 UPGRADED MODEL 9876E
CONTROL SYSTEM SOFTWARE (SERIES 0 & 1)
(BEAD-BLASTED FINISH)
WITH UPGRADED
MODEL 9876E SOFTWARE
(SERIES 0 AND
SERIES 1)
P910031/S001 ENDOSONICS ORACLE ENDOSONICS CORPORATION NEW MODEL: ORACLE
06/05/95 MICRO PLUS RANCHO CORDOVA, CA MICRO PLUS PTCA
PTCA CATHETER 95670 CATHETER
P910073/S014 ENDOTAK SQ LEAD CARDIAC PACEMAKERS, INC. ALTERNATE
06/07/95 ARRAY MODEL 0048 ST. PAUL, MN STERILIZATION
PROCESS
55112-5798 USING OXYFUME 2000
P930029/S002 ATAKR RFCA SYSTEM MEDTRONIC CARDIORHYTHM ADDITION OF THE RF
06/23/95 SAN JOSE, CA MARINR NTC AND
95134-1806 ASSOCIATED CABLING TO
THE ATAKR RFCA SYSTEM
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR JUNE 1995.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-147 GENTAMICIN SULFATE CHICKENS SANOFI AN HLTH GENTAMICIN SULFATE
10-APR-95 (INJECTABLE) OVERLAND PK, KS 100MG/ML
66210
200-108 DEXAMETHASONE CATS, PHOENIX PHARMA DEXAMETHASONE
13-APR-95 (SOLUTION) CATTLE, ST JOSEPH, MO 2MG/ML
DOGS, 64506
HORSES
200-117 OXYSHOT LA CATTLE CROSS VETPHARM GROUP OXYTETRACYCLINE
13-APR-95 (SOLUTION) TALLAGHT, DUBLIN 24, 200MG/ML
IRELAND
200-122 SOLU-PEN TURKEYS WADE JONES PENICILLIN G
17-APR-95 (POWDER) LOWELL, AR POTASSIUM
72745 0.384 BILLION
UNITS/
PACKET
200-139 CHANAZINE CERVIDAE, CHANELLE PHARMA XYLAZINE
16-MAY-95 (SOLUTION) HORSES LOUGHREA, CNTY GALWAY, HYDROCHLORIDE
IRELAND 100MG/ML
200-027 NICARMIX CHICKENS, PLANALQUIMICA IND NICARBAZIN
28-JUN-95 (PREMIX) EXCEPT SAO PAULO, BRAZIL 25%
LAYING HENS
***SUPPLEMENTAL VETERINARY NADAs***
038-233 RALGRO MAGNUM CATTLE MALLINCKRODT VET ZERANOL
06-APR-95 (IMPLANT) MUNDELEIN, IL 72MG/IMPLANT
60060
096-298 AVATEC CHUKAR HOFFMANN LA ROCHE LASALOCID SODIUM
19-APR-95 (PREMIX) PARTRIDGES NUTLEY, NJ 20%
07110
096-298 AVATEC TURKEYS HOFFMANN LA ROCHE LASALOCID SODIUM
28-APR-95 (PREMIX) NUTLEY, NJ 20%
07110
Date created: October 30, 1996; last updated: June 20, 2005 |
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