 |
 |
 |
|
 | |||||
| |||||||||
 | |||||||||
|
|
 |
|
|
FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 19 Number (8) August 1996
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
19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC
01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL
(SUPPL-013) 45285 (NEW INDICATION --
TREATMENT OF ADULT-ONSET
OR CHILDHOOD-ONSET ADULT
GROWTH HORMONE DEFICIENCY)
20-165 NICODERM CQ ALZA NICOTINE
02-AUG-96 (FILM, PALO ALTO, CA 7MG/24HR
(SUPPL-011) EXTENDED RELEASE) 94303 14MG/24HR
21MG/24HR
(RX TO OTC SWITCH)
(OTC)
20-450 CEREBYX PARKE DAVIS FOSPHENYTOIN SODIUM
05-AUG-96 (INJECTABLE) ANN ARBOR, MI EQ 50MG PHENYTOIN SODIUM/ML
(1 S) 48106 (ANTICONVULSANT)
20-248 INTRALIPID 20% PHARMACIA AND UPJOHN SOYBEAN OIL
07-AUG-96 (INJECTABLE) KALAMAZOO, MI 20%
(3 S) 49001 (CALORIC SUPPLEMENT)
20-559 TRITEC GLAXO WELLCOME RANITIDINE BISMUTH CITRATE
08-AUG-96 (TABLET) RES TRIANGLE PK, NC 400MG
(2,4 S) 27709 (HISTAMINE H-2 RECEPTOR
ANTAGONIST/CYTOPROTECTANT)
[TREATMENT OF PATIENTS
WITH
AN ACTIVE DUODENAL ULCER
ASSOCIATED WITH
HELICOBACTER PYLORI
INFECTION (IN COMBINATION
WITH CLARITHROMYCIN)]
20-640 TAVIST-D SANDOZ PHARMS CLEMASTINE FUMARATE
09-AUG-96 (TABLET, EAST HANOVER, NJ 1.34MG
(3 S) EXTENDED RELEASE) 07936 PHENYLPROPANOLAMINE
HYDROCHLORIDE
75MG
(ANTIHISTAMINE/
DECONGESTANT)
(OTC)
20-273 DOVONEX WESTWOOD SQUIBB CALCIPOTRIENE
15-AUG-96 (OINTMENT) BUFFALO, NY 0.005%
(SUPPL-001) 14213 (NEW DOSAGE REGIMEN --
USE FOR UP TO ONE
YEAR FOR THE TREATMENT
OF MODERATE PLAQUE
PSORIASIS)
20-503 PROVENTIL-HFA 3M ALBUTEROL SULFATE
15-AUG-96 (AEROSOL, METERED) SAINT PAUL, MN EQ 0.09MG BASE/INH
(3 S) 55144 (BETA-2 AGONIST)
[TREATMENT OR PREVENTION
OF BRONCHOSPASM IN
PATIENTS 12 YEARS OF
AGE AND OLDER WITH
REVERSIBLE OBSTRUCTIVE
AIRWAY DISEASE]
20-627 LEVONORGESTREL WYETH AYERST LEVONORGESTREL
15-AUG-96 (IMPLANT) PHILADELPHIA, PA 75MG/IMPLANT
(3 S) 19101 (PROGESTIN)
[PREVENTION OF PREGNANCY]
50-719 HELIDAC PROCTER AND GAMBLE BISMUTH SUBSALICYLATE
15-AUG-96 (TABLET, CHEWABLE; CINCINNATI, OH 262.4MG/TABLET, CHEWABLE
(4 S) TABLET; 45242 METRONIDAZOLE
CAPSULE) 250MG/TABLET
TETRACYCLINE HYDROCHLORIDE
500MG/CAPSULE
(ANTIULCER)
[USE IN COMBINATION WITH
AN H-2 ANTAGONIST FOR THE
TREATMENT OF PATIENTS
WITH AN ACTIVE DUODENAL
ULCER ASSOCIATED WITH
HELICOBACTER PYLORI
INFECTION]
20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE
21-AUG-96 (TABLET) PARSIPPANY, NJ 200MG
(SUPPL-001) 07054 (NEW STRENGTH)
(OTC)
19-415 FERTINEX SERONO UROFOLLITROPIN
23-AUG-96 (INJECTABLE) NORWELL, MA 75IU/AMP
(SUPPL-009) 02061 150IU/AMP
(NEW ROUTE
OF ADMINISTRATION --
SUBCUTANEOUS)
20-470 CLARITIN-D 24 HOUR SCHERING LORATADINE
23-AUG-96 (TABLET, KENILWORTH, NJ 10MG
(3 S) EXTENDED RELEASE) 07033 PSEUDOEPHEDRINE SULFATE
240MG
(ANTIHISTAMINE/
DECONGESTANT)
[RELIEF OF SYMPTOMS OF
SEASONAL ALLERGIC
RHINITIS]
20-604 SEROSTIM SERONO SOMATROPIN, BIOSYNTHETIC
23-AUG-96 (INJECTABLE) NORWELL, MA 5MG/VIAL
(5 P, AA*, V**) 02061 6MG/VIAL
(HUMAN GROWTH HORMONE)
[TREATMENT OF AIDS WASTING
AND CACHEXIA]
20-532 IVY BLOCK ENVIRODERM BENTOQUATAM
26-AUG-96 (LOTION) LOUISVILLE, KY 5%
(1 P) 40203 (PROTECTANT)
[PROTECTS AGAINST
POISON IVY, POISON OAK,
AND POISON SUMAC WHEN
APPLIED BEFORE CONTACT]
(OTC)
20-508 LAC-HYDRIN BRISTOL MYERS AMMONIUM LACTATE
29-AUG-96 (CREAM) BUFFALO, NY EQ 12% BASE
(3 S) 14213 (HUMECTANT)
[TREATMENT OF ICHTHYOSIS
VULGARIS AND XEROSIS]
20-416 FERIDEX I.V. ADV MAGNETICS FERUMOXIDES
30-AUG-96 (INJECTABLE) CAMBRIDGE, MA EQ 11.2MG IRON/ML
(1 S) 02138 (MRI CONTRAST MEDIUM)
[AN ADJUNCT TO MRI
(IN ADULT PATIENTS)
TO ENHANCE T2 WEIGHTED
IMAGES USED IN THE
DETECTION AND EVALUATION
OF LESIONS OF THE LIVER
THAT ARE ASSOCIATED WITH
AN ALTERATION IN THE
RETICULOENDOTHELIAL
SYSTEM (RES)]
AA* - Priority Classification AIDS Drug
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.
20-619 BETOPTICPILO ALCON BETAXOLOL HYDROCHLORIDE
01-AUG-96 (SUSPENSION) FORT WORTH, TX 0.25%
76134 PILOCARPINE HYDROCHORIDE
1.75%
(ADRENOCEPTOR ANTAGONIST/
CHOLINERGIC AGONIST)
20-587 SCLEROSOL BRYAN TALC
09-AUG-96 (AEROSOL, POWDER) WOBURN, MA 4GM
01801 (MINERAL)
20-592 ZYPREXA LILLY OLANZAPINE
30-AUG-96 (TABLET) INDIANAPOLIS, IN 2.5MG
46285 5MG
7.5MG
10MG
(ANTIPSYCHOTIC)
***ORIGINAL ABBREVIATED NDAs***
74-072 ALBUTEROL MEDISOL ALBUTEROL
01-AUG-96 (AEROSOL, METERED) EAST HANOVER, NJ 0.09MG/INH
07936 (BETA-2 AGONIST)
74-147 METOCLOPRAMIDE HCL SANOFI WINTHROP METOCLOPRAMIDE
02-AUG-96 (INJECTABLE) NEW YORK, NY HYDROCHLORIDE
10016 EQ 5MG BASE/ML
(UPPER GI TRACT
MOTILITY STIMULATOR)
74-537 SELEGILINE HCL NOVOPHARM SELEGILINE HYDROCHLORIDE
02-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 5MG
CANADA (ANTIDYSKINETIC)
74-565 SELEGILINE HCL ENDO LABS SELEGILINE HYDROCHLORIDE
02-AUG-96 (TABLET) GARDEN CITY, NY 5MG
11530 (ANTIDYSKINETIC)
74-641* SELEGILINE HCL LEDERLE SELEGILINE HYDROCHLORIDE
02-AUG-96 (TABLET) PEARL RIVER, NY 5MG
10965 (ANTIDYSKINETIC)
40-137 CHLORZOXAZONE CHELSEA LABS CHLORZOXAZONE
09-AUG-96 (TABLET) CINCINNATI, OH 500MG
45215 (SKELETAL MUSCLE RELAXANT)
40-159 MEDROXYPROGESTERONE BARR MEDROXYPROGESTERONE ACETATE
09-AUG-96 ACETATE POMONA, NY 2.5MG
(TABLET) 10970 5MG
10MG
(PROGESTIN)
74-582* DANAZOL BARR DANAZOL
09-AUG-96 (CAPSULE) POMONA, NY 200MG
10970 (ANTERIOR PITUITARY
SUPPRESSANT)
72-273 ALBUTEROL ARMSTRONG PHARMS ALBUTEROL
14-AUG-96 (AEROSOL, METERED) WEST ROXBURY, MA 0.09MG/INH
02132 (BETA-2 AGONIST)
74-390 DICLOFENAC SODIUM NOVOPHARM DICLOFENAC SODIUM
15-AUG-96 (TABLET, SCARBOROUGH, ONTARIO 75MG
DELAYED RELEASE) CANADA (NONSTEROIDAL
ANTI-INFLAMMATORY)
* - First Time Product Available Generically
74-557 LOCHOLEST EON LABS CHOLESTYRAMINE
15-AUG-96 (POWDER) LAURELTON, NY EQ 4GM RESIN/SCOOPFUL
11413 EQ 4GM RESIN/PACKET
(ANTIHYPERLIPIDEMIC)
74-558 LOCHOLEST LIGHT EON LABS CHOLESTYRAMINE
15-AUG-96 (POWDER) LAURELTON, NY EQ 4GM RESIN/SCOOPFUL
11413 EQ 4GM RESIN/PACKET
(ANTIHYPERLIPIDEMIC)
74-561 LOCHOLEST EON LABS CHOLESTYRAMINE
15-AUG-96 (POWDER) LAURELTON, NY EQ 4GM RESIN/SCOOPFUL
11413 EQ 4GM RESIN/PACKET
(ANTIHYPERLIPIDEMIC)
74-562 LOCHOLEST LIGHT EON LABS CHOLESTYRAMINE
15-AUG-96 (POWDER) LAURELTON, NY EQ 4GM RESIN/SCOOPFUL
11413 EQ 4GM RESIN/PACKET
(ANTIHYPERLIPIDEMIC)
40-125 THIORIDAZINE HCL HI TECH THIORIDAZINE HYDROCHLORIDE
16-AUG-96 (CONCENTRATE) AMITYVILLE, NY 30MG/ML
11701 (ANTIPSYCHOTIC)
40-126 THIORIDAZINE HCL HI TECH THIORIDAZINE HYDROCHLORIDE
16-AUG-96 (CONCENTRATE) AMITYVILLE, NY 100MG/ML
11701 (ANTIPSYCHOTIC)
64-118 NYSTOP PADDOCK LABS NYSTATIN
16-AUG-96 (POWDER) MINNEAPOLIS, MN 100,000 UNITS/GM
55427 (ANTIFUNGAL)
74-621+ MEGESTROL ACETATE BARR MEGESTROL ACETATE
16-AUG-96 (TABLET) POMONA, NY 20MG
10970 (PROGESTERONE DERIVATIVE)
74-584 BACLOFEN ROSEMONT BACLOFEN
19-AUG-96 (TABLET) DENVER, CO 10MG
80223 20MG
(SKELETAL MUSCLE RELAXANT)
74-698 BACLOFEN CHELSEA LABS BACLOFEN
20-AUG-96 (TABLET) CINCINNATI, OH 10MG
45215 20MG
(SKELETAL MUSCLE RELAXANT)
+ - Supplemental Abbreviated NDA
40-146 FLUPHENAZINE HCL PHARM ASSOC FLUPHENAZINE HYDROCHLORIDE
21-AUG-96 (ELIXIR) CONESTEE, SC 2.5MG/5ML
29636 (ANTIPSYCHOTIC)
40-102 METHAZOLAMIDE INVAMED METHAZOLAMIDE
28-AUG-96 (TABLET) DAYTON, NJ 25MG
08810 50MG
(CARBONIC ANHYDRASE
INHIBITOR)
64-065 OTICAIR BAUSCH AND LOMB HYDROCORTISONE
28-AUG-96 (SUSPENSION/DROPS) TAMPA, FL 1%
33637 NEOMYCIN SULFATE
EQ 3.5MG BASE/ML
POLYMYXIN B SULFATE
10,000 UNITS/ML
(ANTIBIOTIC/CORTICOSTEROID)
20-512 CLINISOL 15% CLINTEC NUTR AMINO ACIDS
30-AUG-96 SULFITE FREE DEERFIELD, IL 15%
IN PLASTIC CONTAINER 60015 (NUTRIENT REPLENISHER)
(INJECTABLE)
40-168 HYDROCORTISONE MORTON GROVE ACETIC ACID, GLACIAL
30-AUG-96 AND ACETIC ACID MORTON GROVE, IL 2%
(SOLUTION/DROPS) 60053 HYDROCORTISONE
1%
(ASTRINGENT/CORTICOSTEROID)
74-229 NADOLOL ZENITH GOLDLINE NADOLOL
30-AUG-96 (TABLET) NORTHVALE, NJ 20MG
07647 40MG
(BETA ADRENERGIC BLOCKER)
74-349 CIMETIDINE DANBURY PHARMA CIMETIDINE
30-AUG-96 (TABLET) DANBURY, CT 200MG
06810 300MG
400MG
(HISTAMINE H-2 RECEPTOR
ANTOGONIST)
74-531 FLUPHENAZINE BEDFORD LABS FLUPHENAZINE DECANOATE
30-AUG-96 DECANOATE BEDFORD, OH 25MG/ML
(INJECTABLE) 44146 (ANTIPSYCHOTIC)
74-546* CLOZAPINE CREIGHTON CLOZAPINE
30-AUG-96 (TABLET) EAST HANOVER, NJ 25MG
07936 100MG
(ANTIPSYCHOTIC)
* - First Time Product Available Generically
74-559 NITROGLYCERIN MYLAN PHARM NITROGLYCERIN
30-AUG-96 (FILM, MORGANTOWN, WV 0.6MG/HR
EXTENDED RELEASE) 26504 (VASODILATOR)
74-590 CAPTOPRIL BAKER NORTON CAPTOPRIL
30-AUG-96 (TABLET) MIAMI, FL 12.5MG
33137 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-607 NITROGLYCERIN MYLAN PHARMS NITROGLYCERIN
30-AUG-96 (FILM, MORGANTOWN, WV 0.4MG/HR
EXTENDED RELEASE) 26504 (VASODILATOR)
74-609 NITROGLYCERIN MYLAN PHARMS NITROGLYCERIN
30-AUG-96 (FILM, MORGANTOWN, WV 0.2MG/HR
EXTENDED RELEASE) 26504 (VASODILATOR)
***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS***
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.
74-635 NAPROXEN SODIUM NOVOPHARM NAPROXEN SODIUM
20-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 220MG
CANADA (NONSTEROIDAL
ANTI-INFLAMMATORY)
74-570 ACYCLOVIR ROXANE LABS ACYCLOVIR
30-AUG-96 (CAPSULE) COLUMBUS, OH 200MG
43216 (ANTIVIRAL)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
08-678 ISONIAZID EON MANUFACTURE LABS ISONIAZID
01-AUG-96 (TABLET) LAURELTON, NY 100MG
11413 300MG
(LABELING REVISION --
OVERDOSAGE)
19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC
01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL
45285 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
17-407 CATAPRES BOEHRINGER INGELHEIM CLONIDINE HYDROCHLORIDE
02-AUG-96 (TABLET) RIDGEFIELD, CT 0.1MG
06877 0.2MG
0.3MG
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE; DOSAGE
AND ADMINISTRATION)
20-165 NICODERM CQ ALZA NICOTINE
02-AUG-96 (FILM, PALO ALTO, CA 7MG
EXTENDED RELEASE) 94303 14MG
21MG
(LABELING REVISION --
PATIENT LABELING)
(OTC)
19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC
05-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL
45285 (LABELING REVISION --
PRECAUTIONS;
INFORMATION FOR PATIENTS;
ADVERSE REACTIONS)
19-949 DIFLUCAN PFIZER CENTRAL RES FLUCONAZOLE
06-AUG-96 (TABLET) GROTON, CT 50MG
06340 100MG
150MG
200MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-950 DIFLUCAN PFIZER FLUCONAZOLE
06-AUG-96 (INJECTABLE) NEW YORK, NY 2MG/ML
10017 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
20-090 DIFLUCAN PFIZER FLUCONAZOLE
06-AUG-96 (POWDER NEW YORK, NY 50MG/5ML
FOR RECONSTITUTION) 10017 200MG/5ML
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
09-AUG-96 (CAPSULE, WAYNE, PA 10MG
DELAYED RELEASE 19087 20MG
PELLETS) (LABELING REVISION --
ADVERSE REACTIONS;
OVERDOSAGE)
19-847 CIPRO IV BAYER CIPROFLOXACIN
09-AUG-96 (INJECTABLE) WEST HAVEN, CT 10MG/ML
06516 (LABELING REVISION --
ADVERSE REACTIONS)
19-857 CIPRO IV BAYER CIPROFLOXACIN
09-AUG-96 IN DEXTROSE 5% WEST HAVEN, CT 200MG/100ML
IN PLASTIC CONTAINER 06516 (LABELING REVISION --
(INJECTABLE) ADVERSE REACTIONS)
50-573 SANDIMMUNE SANDOZ PHARM CYCLOSPORINE
09-AUG-96 (INJECTABLE) EAST HANOVER, NJ 50MG/ML
07936 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-574 SANDIMMUNE SANDOZ PHARM CYCLOSPORINE
09-AUG-96 (SOLUTION) EAST HANOVER, NJ 100MG/ML
07936 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-625 SANDIMMUNE SANDOZ PHARM CYCLOSPORINE
09-AUG-96 (CAPSULE) EAST HANOVER, NJ 25MG
07936 50MG
100MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-474 VEXOL ALCON LABS RIMEXOLONE
14-AUG-96 (SUSPENSION/DROPS) FOR WORTH, TX 1%
76134 (LABELING REVISION --
DOSAGE AND ADMINISTRATION)
50-143 CHLOROMYCETIN PARKE DAVIS CHLORAMPHENICOL
14-AUG-96 (POWDER MORRIS PLAINS, NJ 25MG/VIAL
FOR RECONSTITUTION) 07950 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-273 DOVONEX WESTWOOD SQUIBB CALCIPOTRIENE
15-AUG-96 (OINTMENT) BUFFALO, NY 0.005%
14213 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-392 CYSTAGON MYLAN CYSTEAMINE BITARTRATE
16-AUG-96 (CAPSULE) MORGANTOWN, WV EQ 50MG BASE
26505 EQ 150MG BASE
(LABELING REVISION --
DESCRIPTION; WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE; HOW SUPPLIED)
50-578 FORTAZ GLAXO WELLCOME CEFTAZIDIME
20-AUG-96 (INJECTABLE) RES TRIANGLE PK, NC 500MG/VIAL
27709 1GM/VIAL
2GM/VIAL
6GM/VIAL
(LABELING REVISION --
ADVERSE REACTION)
50-580 AZACTAM BRISTOL MYERS SQUIBB AZTREONAM
20-AUG-96 (INJECTABLE) PRINCETON, NJ 500MG/VIAL
08543 1GM/VIAL
2GM/VIAL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS;
ADVERSE REACTIONS)
50-632 AZACTAM BRISTOL MYERS SQUIBB AZTREONAM
20-AUG-96 IN PLASTIC CONTAINER PRINCETON, NJ 20MG/ML
(INJECTABLE) 08543 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS;
ADVERSE REACTIONS)
50-634 FORTAZ GLAXO WELLCOME CEFTAZIDIME SODIUM
20-AUG-96 IN PLASTIC CONTAINER RES TRIANGLE PK, NC EQ 10MG BASE/ML
(INJECTABLE) 27709 EQ 20MG BASE/ML
EQ 40MG BASE/ML
(LABELING REVISION --
ADVERSE REACTIONS)
50-646 CEPTAZ GLAXO WELLCOME CEFTAZIDIME
20-AUG-96 (INJECTABLE) RES TRIANGLE PK, NC (ARGININE FORMULATION)
27709 500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE
21-AUG-96 (TABLET) PARSIPPANY, NJ 200MG
07054 (LABELING REVISION --
PATIENT INFORMATION)
(OTC)
19-415 FERTINEX SERONO LABS UROFOLLITROPIN
23-AUG-96 (INJECTABLE) NORWELL, MA 75IU/AMP
02061 150IU/AMP
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-264 PENTAM 300 FUJISAWA USA PENTAMIDINE ISETHIONATE
27-AUG-96 (INJECTABLE) DEERFIELD, IL 300MG/VIAL
60015 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS; WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-779 IOPIDINE ALCON LABS APRACLONIDINE
27-AUG-96 (SOLUTION/DROPS) FORT WORTH, TX HYDROCHLORIDE
76134 1%
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS)
50-156 CHLOROMYCETIN PARKE DAVIS CHLORAMPHENICOL
27-AUG-96 (OINTMENT) MORRIS PLAINS, NJ 1%
07950 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-201 OPHTHOCORT PARKE DAVIS CHLORAMPHENICOL
27-AUG-96 (OINTMENT) MORRIS PLAINS, NJ 10MG/GM
07950 HYDROCORTISONE ACETATE
5MG/GM
POLYMYXIN B SULFATE
100,000 UNITS/GM
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-486 VIRA-A PARKE DAVIS VIDARABINE
27-AUG-96 (OINTMENT) MORRIS PLAINS, NJ 3%
07950 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
15-923 HALDOL JOHNSON RW HALOPERIDOL
28-AUG-96 (INJECTABLE) SPRING HOUSE, PA EQ 5MG BASE/ML
19477 (LABELING REVISION --
HOW SUPPLIED)
20-180 PROSCAR MERCK RES LABS FINASTERIDE
28-AUG-96 (TABLET) WESTPOINT, PA 5MG
19486 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECUATIONS;
HOW SUPPLIED;
PATIENT PACKAGE INSERT)
19-651 ASACOL PROCTER GMBL PHARMS MESALAMINE
30-AUG-96 (TABLET, NORWICH, NY 400MG
DELAYED RELEASE) 13815 (LABELING REVISION --
ADVERSE REACTIONS)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
0226 NONE BLOOD BANKS OF SOURCE PLASMA
08-06-96 (INJECTABLE) SAN BERNARDINO AND (B)
RIVERSIDE CNTYS
SAN BERNARDINO, CA
92412
1207 CALYPTE HIV-1 CALYPTE BIOMED HIV-TYPE 1 (RECOMBINANT)
08-06-96 URINE EIA BERKELY, CA (KIT USED IN DETECTION OF
(IN VITRO) ANTIBODIES TO THE HIV
PRESENT IN URINE)
(A,B)
1199 VERLUMA DR KARL THOMAE GMBH NOFETUMOMAB
08-20-96 (NONE) GERMANY (IMAGING AGENT FOR DETECTION
OF EXTENSIVE STAGE DISEASE
IN PATIENTS WITH BIOPSY-
CONFIRMED, PREVIOUSLY
UNTREATED, SMALL CELL
LUNG CANCER)
(A,B)
0991 NONE AM-RHO LABS SOURCE PLASMA
08-22-96 (INJECTABLE) CHARLESTON, GA (B)
30021
1202 NONE CENTEON PHARMA GMBH ANTIHEMOPHILIC FACTOR
08-22-96 (INJECTABLE) GERMANY (HUMAN)
(FOR FURTHER MANUFACTURING
USE)
(A,B)
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK960054 JEWETT MODELS JEWETT REFRIGERATOR BLOOD STORAGE REFRIGERATORS
08-08-96 BPL13, BPL21, BUFFALO, NY AND FREEZERS
BPL25 14213 (C)
BK960002 ACT BUOYANT ACTIVATED CELL THERAPY SILANATED COLLODIAL SILICA
08-12-96 DENSITY SOLUTION MOUNTAIN VIEW, CA SUPPLEMENTED WITH
94043 POLYVINYNOLIDONE
(C)
BK950037 COMPONENTS AND INFORMATION DATA MANGMNT CDIS
08-26-96 DISTRIBUTION ROSEMONT, IL (C)
INFORMATION SYSTEM 60018
BK950045 DONOR MANAGEMENT INFORMATION DATA MANGMNT DMIS
08-26-96 INFORMATION SYSTEMS ROSEMONT, IL (C)
VERS. 1.2 60018
(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
P940036 BARTELS BARTELS PROGNOSTICS, AN IN VITRO
08/01/96 CHEMORESPONSE INC. DIAGNOSTIC DEVICE
ASSAY ISSAQUAH, WA INTENDED FOR USE TO
98027 DETERMINE RESISTANCE
TO 5-FLUOROURACIL
(5-FU) OF CELLS
ISOLATED FROM BREAST
TUMORS WHICH WILL
ASSIST PHYSICIANS IN
DETERMINING IF 5-FU
IS AN INEFFECTIVE
TREATMENT FOR
RELAPSED BREAST
CANCER PATIENTS
P950034 SEPRAFILM GENZYME CORP. THE DEVICE IS
08/12/96 BIORESORBABLE CAMBRIDGE, MA INDICATED FOR USE
MEMBRANE 02139-1562 IN PATIENTS
UNDERGOING ABDOMINAL
OR PELVIC LAPAROTOMY
AS AN ADJUNCT
INTENDED TO REDUCE
THE INCIDENCE, EXTENT,
AND SEVERITY OF
POSTOPERATIVE
ADHESIONS BETWEEN
THE ABDOMINAL WALL
AND THE UNDERLYING
VISCERA
P960020 RELIANCE URINARY UROMED CORP. THE DEVICE IS
08/16/96 CONTROL INSERT NEEDHAM, MA INDICATED FOR THE
AND SIZING DEVICE 02194 MANAGEMENT OF STRESS
URINARY INCONTINENCE
IN ADULT WOMEN
***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
N50510/S069 VITEK GENERAL BIOMERIEUX VITEK, INC. REMOVAL OF
08/07/96 SUSCEPTIBILITY HAZELWOOD, MO LIMITATION FOR
CARD 63042-2395 SUSCEPTIBILITY
TESTING OF
ENTEROCOCCI/
VANCOMYCIN TESTING
ON THE DEVICE
P790018/S027 MEDTRONIC-HALL MEDTRONIC, INC. TRANSFER OF SEWING
08/19/96 PROSTHETIC HEART IRVINE, CA RING FABRICATION AND
VALVE, MODELS 92714 ATTACHMENT, AND
A7700 AND M7700 STERILE PACKAGING
MANUFACTURING
PROCESSES FROM THE
MINNEAPOLIS,
MN, FACILITY TO THE
IRVINE, CA, FACILITY
P830026/S067 COSMOS/NOVA/QUANT INTERMEDICS, INC. APPROVAL FOR THE USE
08/19/96 UM/SUPRIMA/PULSE ANGLETON, TX OF AN ALTERNATE
GENERATORS 77515 CONDUCTIVE EPOXY AND
A PRODUCTION PROCESS
CHANGE FOR AUTOMATED
APPLICATION OF THIS
EPOXY IN THE
MANUFACTURE OF
IMPLANTABLE PULSE
GENERATORS
P830061/S026 MEDTRONIC MEDTRONIC, INC. ALTERNATE PACKAGING
08/12/96 PACING LEADS MINNEAPOLIS, MN DESIGN
55432-3576
P830056/S077 POSTERIOR CHAMBER MENTOR OPTHALMICS APPROVAL FOR A
08/01/96 INTRAOCULAR SANTA BARBARA, CA MANUFACTURING SITE
LENSES 93111 LOCATED AT CIDRA,
PR 00639
P830063/S001 GAMBRO AB GAMBRO, INC. CHANGE OF MATERIAL
08/28/96 PLASMAFILTER LAKEWOOD, CO USED IN THE HOUSING
PF 2000N AND 80215 OF THE DEVICE, END
EXCORIM KB MAXO CAP CONFIGURATION
PLASMAFILTER MODIFICATION, AND
SPECIFICATION CHANGES
TO THE DEVICE
MEMBRANE
P840024/S066 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR
08/28/96 CHANNEL COCHLEAR ENGLEWOOD, CO IMPLEMENTING A NEW
IMPLANT SYSTEM 80112 DIAGNOSTIC AND
PROGRAMMING SYSTEM
SOFTWARE (DPS
VERSION 6.125)
P850035/S020 EBI SPF ELECTRO-BIOLOGY, INC. THE DEVICE IS
08/20/96 IMPLANTABLE PARSIPPANY, NJ INDICATED FOR USE AS
SPINAL FUSION 07054-1079 A SPINAL FUSION
STIMULATOR MODEL ADJUNCT TO INCREASE
SPF-XL II THE PROBABILITY OF
FUSION SUCCESS IN 3
OR MORE LEVELS
P850079/S028 HYDRASOFT, COOPERVISION, INC. APPROVAL FOR
08/01/96 HYDRASOFT TORIC, IRVINE, CA REFORMATTING THE
HYDRASOFT XW AND 92718 PACKAGE INSERT,
HYDRASOFT TORIC XW PROFESSIONAL FITTING
(METHALICON B) AND INFORMATION
SOFT (HYDROPHILIC) GUIDE, AND PATIENT
CONTACT LENSES INSTRUCTIONS
P850089/S034 MEDTRONIC MEDTRONIC, INC. ALTERNATIVE PACKAGING
08/12/96 PACING LEADS MINNEAPOLIS, MN DESIGN
55432-3576
P860007/S018 INTERTACH II INTERMEDICS, INC. APPROVAL FOR THE USE
08/19/96 MODELS 262-16 ANGLETON, TX OF AN ALTERNATE
77515 CONDUCTIVE EPOXY AND
A PRODUCTION PROCESS
CHANGE FOR AUTOMATED
APPLICATION OF THIS
EPOXY IN THE
MANUFACTURE OF
IMPLANTABLE PULSE
GENERATORS
P860019/S112 SCIMED RANGER SCIMED LIFE SYSTEMS, THE DEVICE IS
08/29/96 PERCUTANEOUS INC. INDICATED FOR THE
TRANSLUMINAL MAPLE GROVE, MN BALLOON DILATATION
ANGIOPLASTY 55311-1566 OF THE STENOTIC
(PTCA) CATHETER PORTION OF A
CORONARY ARTERY OR
BYPASS GRAFT
STENOSIS FOR THE
PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION
P860019/S114 SCIMED NC BANDIT SCIMED LIFE SYSTEMS, MODIFICATION TO THE
08/27/96 PERCUTANEOUS INC. WRAP-IT ACCESSORY
TRANSLUMINAL MAPLE GROVE, MN TOOL
CORONARY 55311-1566
ANGIOPLASTY (PTCA)
CATHETER
P870015/S022 MEDSTONE STS MEDSTONE INTL., INC. HARDWARE AND
08/19/96 LITHOTRIPTER ALISO VIEJO, CA SOFTWARE CHANGES
92656-4114 TO THE DEVICE
P870036/S039 MEDTRONIC MEDTRONICS NEW BALLOON SIZES
08/30/96 FALCON CORONARY INTERVENTIONAL TO BE ADDED TO THE
BALLOON SAN DIEGO, CA FALCON 20 CORONARY
DILATATION 92121-2256 BALLOON DILATATION
CATHETERS CATHETER LINE AND
THE ADDITION OF THE
FALCON 30 AND FALCON
40 CORONARY BALLOON
DILATATION CATHETER
LINES ADDITIONALLY,
SPECIFICATION AND
QUALITY CONTROL
INSPECTION CHANGES
WERE REQUESTED
P880040/S003 CELLFREE T CELL DIAGNOSTICS, CHANGE IN ADDRESS OF
08/07/96 INTERLEUKIN-2 INC. THE MANUFACTURING
RECEPTOR BEAD WOBURN, MA SITE AND UPDATES AND
ASSAY KIT 01801 REVISIONS IN STANDARD
OPERATING PROCEDURES
AND MANUFACTURING
INFORMATION
P890003/S045 MEDTRONIC VDD MEDTRONIC, INC. ALTERNATIVE PACKAGING
08/12/96 STEROID-ELUTING MINNEAPOLIS, MN DESIGN
LEAD 55432-3576
P890023/S004 OCUFILCON D OCULAR SCIENCES/ 1)ADDITION OF AN IN-
08/28/96 SPHERICAL AND AMERICAN HYDRON MONOMER TINT
TORIC EXTENDED CUPERTINO, CA INCORPORATING VAT
WEAR CONTACT 95014 BLUE 6 DYE DURING THE
LENSES POLYMERIZATION PHASE
OF THE MANUFACTURING
PROCESS; 2) USE OF
BLISTER PACKAGING AS
ALTERNATE PACKAGING
MATERIAL; AND 3)
ALTERNATE
MANUFACTURING SITE
P890027/S035 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR
08/28/96 CHANNEL COCHLEAR ENGLEWOOD, CO IMPLEMENTING A NEW
IMPLANT 80112 DIAGNOSTIC AND
PROGRAMMING SYSTEM
SOFTWARE (DPS
VERSION 6.125)
P890064/S004 HYBRID DIGENE DIAGNOSTICS, CHANGES IN
08/28/96 CAPTURE HPV INC. MANUFACTURING
DNA ASSAY SILVER SPRING, MD METHODS, PROCEDURES,
20904 AND LABELING
MODIFICATIONS
P900023/S019 ABIOMED ABIOMED, INC. ELIMINATION OF THE
08/19/96 BVS 5000 DANVERS, MA ISOLATOR VALVE
BI-VENTRICULAR 01923 ASSEMBLY FROM THE BVS
SUPPORT SYSTEM CONSOLE
P900060/S011 CARBOMEDICS CARBOMEDICS, INC. APPROVAL FOR THE 21MM
08/12/96 PROSTHETIC HEART AUSTIN, TX MITRAL CPHV, MODEL
VALVE (CPHV) 78752-1793 M700
P900060/S013 CARBOMEDICS CARBOMEDICS, INC. APPROVAL FOR THE
08/27/96 PROSTHETIC HEART AUSTIN, TX USE OF AN ALTERNATE
VALVE (CPHV) 78752-1793 CONTROLLED
MODELS A500, ENVIRONMENT FOR
R500, S500, M700, CPHV MANUFACTURING
MAND S700 OPERATIONS
P900061/S028 MODEL MEDTRONIC, INC. APPROVAL FOR NEW
08/06/96 7221/B/CX/D/E MINNEAPOLIS, MN MODEL AND THE MODEL
MICRO JEWEL 55432-3576 6836Y CONNECTOR
WITH ENDOTAK
SERIES LEADS
INCLUDING 60, 70
AND 110 SERIES
LEADS (MODELS 0060,
0062, 0063, 0064,
0070, 0072, 0073,
0074, 0075, 0113,
0115) AND THE MODEL
6836 Y CONNECTOR
P910020/S015 RELAY/DASH/STRIDE/ INTERMEDICS, INC. APPROVAL FOR THE USE
08/19/96 DART PACING ANGLETON, TX OF AN ALTERNATE
SYSTEMS 77515 CONDUCTIVE EPOXY AND
A PRODUCTION PROCESS
CHANGE FOR AUTOMATED
APPLICATION OF THIS
EPOXY IN THE
MANUFACTURE OF
IMPLANTABLE PULSE
GENERATORS
P910031/S009 FACT BALLOON CARDIOVASCULAR APPROVAL FOR THE
08/20/96 CORONARY DYNAMICS, INC. 22 MM MODELS OF THE
DILATATION IRVINE, CA FACT AND ARC BALLOON
CATHETER AND 92718 CORONARY DILATATION
ARC BALLOON CATHETERS
CORONARY
DILATATION
CATHETER
P920004/S001 VASOSEAL DATASCOPE, CORP. ADDITION OF A REDUCED
08/01/96 VASCULAR MONTVALE, NJ TIME TO AMBULATION
HEMOSTASIS 07645 CLAIM TO THE
DEVICE INDICATIONS FOR USE
P920004/S002 VASOSEAL COLLAGEN PRODUCTS CHANGES TO THE
08/01/96 VASCULAR DIVISION INSTRUCTIONS FOR USE
HEMOSTASIS DEVICE MONTVALE, NJ TO ENHANCE THE
07645 SAFETY OF THE USE OF
THE DEVICE
P920015/S010 MEDTRONIC SPRINT MEDTRONIC, INC. APPROVAL FOR THE
08/06/96 MODEL 6932 MINNEAPOLIS, MN MEDTRONIC SPRINT
LEAD 55432-3576 MODEL 6932 LEAD
P930039/S001 MEDTRONIC MEDTRONIC, INC. ALTERNATIVE PACKAGING
08/12/96 SCREW-IN STEROID MINNEAPOLIS, MN DESIGN
ELUTING LEAD 55432
P940008/S002 RES-Q INTERMEDICS, INC. APPROVAL FOR A
08/20/96 ARRHYTHMIA ANGLETON, TX SUPPLEMENT WHICH
CONTROL DEVICE 77515 SATISFIES THE
SYSTEMS REQUIREMENT TO SUBMIT
A POST-APPROVAL STUDY
PROTOCOL FOR THE
INTERMEDICS
EPICARDIAL PATCH
DEFIBRILLATION LEADS
P940008/S003 RES-Q INTERMEDICS, INC. APPROVAL TO CONSIDER
08/22/96 ARRHYTHMIA ANGLETON, TX THE INFORMATION
CONTROL DEVICE 77515 PROVIDED IN THIS
SYSTEMS SUPPLEMENT AS AN
ALTERNATIVE RESPONSE
TO THE CONDITIONS OF
APPROVAL SET FORTH IN
THE FDA LETTER DATED
NOVEMBER 7, 1995,
WHICH REQUIRED THAT
REMAINING MINOR
SOFTWARE ANOMALIES
BE CORRECTED
P940010/S001 OPTIGUIDE QLT PHOTOTHERAPEUTICS, CHANGE IN LABELING
08/07/96 FIBER OPTIC INC. CONSISTING OF ADDING
DIFFUSER VANCOUVER, B.C., AN ADDITIONAL WARNING
DCYL SERIES STATEMENT CONCERNING
POSSIBLE LEAKAGE OF
BLOOD INTO DIFFUSER
CAP
P940022/S001 CLARION ADVANCED BIONICS, MODIFY THE DESIGN OF
08/02/96 MULTI-STRATEGY CORP. THE CLARION MULTI-
COCHLEAR IMPLANT SYLMAR, CA STRATEGY COCHLEAR
VERSION 1.2 FOR 91342 IMPLANT FROM THE
ADULTS ORIGINAL 1.0 VERSION
TO THE MINIATURIZED
1.2 VERSION
P940034/S003 GEN-PROBE GEN-PROBE, INC. APPROVAL FOR CHANGING
08/22/96 AMPLIFIED SAN DIEGO, CA THE PACKAGE INSERT
MYCOBACTERIUM 92121 FOR THE MTD KIT TO
TUBERCULOSIS INCLUDE AN ADDITIONAL
DIRECT TEST (MTD WARNING AND AN
TEST) EXPANDED LIMITATION
REGARDING LOW
POSITIVE RESULTS WITH
MOTT
P950039/S001 THINPREP CYTYC, CORP. RELOCATION OF CYTYC,
08/22/96 PROCESSOR BOXBOROUGH, MA CORP., FROM
(MODEL TP 2000) 01719 MARLBOROUGH, MA TO
BOXBOROUGH, MA
***ORIGINAL VETERINARY NADAs***
141-063 NUFLOR INJECTABLE CATTLE SCHERING PLOUGH FLORFENICOL
31-MAY-96 SOLUTION AN HLTH 300MG/ML
(SOLUTION) KENILWORTH, NJ
07033
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR AUGUST 1996.
***SUPPLEMENTAL VETERINARY NADAs***
140-897 REVALOR-G CATTLE ROUSSEL UCLAF TRENBOLONE ACETATE
02-JUL-96 (EAR IMPLANT) PARIS, FRANCE 20MG/PELLET
ESTRADIOL
4MG/PELLET
140-915 INTERCEPTOR DOGS CIBA GEIGY AN HLTH MILBEMYCIN OXIME
09-JUL-96 FLAVOR TABS GREENSBORO, NC 2.3MG
(TABLET) 27419 5.7MG
11.5MG
23MG
141-034 FLAVOMYCIN CATTLE HOECHST ROUSSEL BAMBERMYCINS
26-AUG-96 (TYPE A AGRI VET 10GM/LB
MEDICATED ARTICLE) SOMERVILLE, NJ
08876
Date created: October 22, 1996; last updated: June 20, 2005 |
|
|
||||||
 | ||||||
|
||||||