Document 6470473

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JUN
T /999
Approval date:
FREEDOM OF INFORMATION
SUMMARY
GENERIC NEW ANIMAL DRUG APPLICATION
ANADA 200-245
Nystatin, neomycin sulfate, thlostrepton and triamcinolone
acetonide cream
Derma-Vet Cream’”
“.. .Derma-Vet Cream is indicated in the management of dermatologic disorders in dogs
and cats, characterized by inflammation and dry or exudative dermatitis, particularly those
caused, complicated or threatened by bacterial or candidal (Candida albicans) infections.
Sponsored by:
Med-Pharmex, Inc.
2727 Thompson Creek Road
Pomona, CA 91767-1861
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Freedom
1.
of Information
Summary.
General Information:
ANADA Number: 200-245
Sponsor Name and Address:
Med-Pharmex, Inc.
2727 Thompson Creek Rd
Pomona, CA 91767-1861
Generic Name:
Nystatin, neomycin sulfate, thiostrepton
and triamcinolone
acetonide cream.
Trade Name:
Derrna-Vet Cream.
Marketing Status: Rx.
2.
Indications for Use:
Derma-Vet Cream is indicated in the management of dermatologic disorders in dogs and
cats, characterized by inflammation and dry or exudative dermatitis, particularly those
caused, complicated or threatened by bacterial or candidal (Candida albicans) infections.
It is also of value in eczematous dermatitis, contact dermatitis and seborrheic dermatitis;
and as an adjunct in the treatment of dermatitis due to parasitic infestation.
3.
Dosage Form(s), Route(s) of Administration
Contraindications:
and Recommended
Dosages and
Dosage Form:
Derrna-Vet Cream is in the form of a cream which is applied onto the infected area.
Route(s) of Administration
and Recommended
Dosages:
The route of administration is by external application of the cream.
The recommended dosage is that the cream is to be applied as a thin film. For mild
inflammations, application may range from once daily to once a week. For severe
conditions, the product may be applied as often as 2 to 3 times daily, if necessary.
Frequency of treatment may be decreased as improvement occurs.
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Freedom of Information
Page 2
Summary
Contraindications:
Derma-Vet Cream should not be used opthalmically.
4.
TARGET ANIMAL SAFETY AND EFFECTIVENESS
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended
by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460,
December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal
drug application (ANADA) may be submitted for a generic version of an
approved new animal drug (pioneer product). New target animal safety data, drug
effectiveness data, and human food safety data (other than tissue residue data) are
not required for approval of an ANADA. Rather, approval of an ANADA relies
on the ANADA sponsor showing that the generic product is bioequivalent to the
pioneer. If bioequivalence is demonstrated through a clinical end-point study,
then a tissue residue study to establish the withdrawal time for the generic product
is also required. For certain dosage forms, the agency will grant a waiver from
conducting an in vivo bioequivalence study (Fifth GADPTRA Policy Letter, 55
FR 24645, June 18, 1990; Bioequivalence Guidance, 1996,61 FR 26182, May
24, 1996).
Based on the formulation characteristics of the
Inc. was granted a waiver from the requirement
for the generic product Derma-Vet Cream. The
a topical ointment and contains the same active
same concentrations as the pioneer product.
5.
generic product, Med-Pharmex,
of an in vivo bioequivalence study
generic product is administered as
and inactive ingredients in the
Human Safety:
This drug is indicated for use only on dogs and cats. It is not to be used for foodproducing animals. Therefore, the issue of residues and human safety does not
arise.
6.
Agency Conclusions:
This ANADA submitted under section 512(b) of the Federal Food, Drug, And
Cosmetic Act satisfies the requirements of section 512(n) of the Act and
demonstrates that Derma-Vet Cream (neomycin sulfate, nystatin, triamcinolone
acetonide, thiostrepton) when used under its proposed conditions of use, is safe
and effective for the labeled indications.
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Freedom of Information
Page 3
Attachment:
Summw
Generic and pioneer labeling
Generic –
Pioneer –
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NYSTATIN-NEOMYCIN
SULFATE-THIOSTREPTONTRIAMCINOLONE
ACETONIDE CREAM VETERINARY
For Topical Use on Dogs and Cats
CAUTION:
Federal law restricts
licensed veterinarian.
ANADA #200-245 Approved by FDA
this drug to use by or on the order of a
~
Nyatatin-Naomycin Suffata-T?riostreptonTdamcfnobne Acetcnide Cream carsbines nystatin, naomycrn
suffate, W@repton,
and tdamcinolane acehmide.
Each gram contains
Nystatin . .. ... ... ... ..... .... . ........ ... ... ... ... ..... .. ... .. .... lC0,000 units
Neamycfn Suffale aquivabnt to neomycin base .... .....2.5 mg.
Thiostrepton ........ .. ... ...... ... .. ..... ....... ..... .. .... .. ......... 2500 units
Trfamclnofene acetonida .. .... ..... ... ... ............. ... ........ . 1.0 mg.
h an aquaeus, nonirritating vanishing cream base with cetearyl
akohef (and) ceteareth-20, ethyiendiamine
hydnxhloride,
methyl paraban, prepyl paraban. propylene giycol, sotitof
solut!ars, Marsium dmxide, sedium citrate, c%ric acid, white
patrofatum, gfyceryt monoaleafate, pefyethyfene gfycol
menoafearate, sorbic ac!d and slrnethmne.
~
By virtue of its feur actke ingredkmts, NystatinNecnrycln Suffata-Thiestrepton-Triamcinolorne
Aca@nida Cream
provides [our basic tharapautii affects: antiinflammatory<
antipiurftic, ant fiungal and antibacterial. Triamcinolone Acatonide
is a potent synthetic catkmsteroid providing rapid and prolonged
sYfWtOmafic refief en Iepical administ ratien. Inflemmatirm.
ac%msa,and pnmitus pmmpfly subside, and Iesiens are permitted
10 fwal. Nystatin is the first wall tolerated antifungal agent
antibmtic of dep%n&bfa efficacy for the traatment of cutaneous
“wfectlwss caused by Camfida afbicans (Monitia). Nystatin is
fungktatii in vitro agaksaf a vadafy et yeast and yeast fike fungi
incfud~
many fungi pathogank to animals. No apprac!able
acttii
la axhibiied agafnaf bacteria. Thiostrepten has a hgh
order d actii~ against gram pesliie organisms, rncluding many
whkfr are resistant to other antibiotics naomyc!m exerts
antimictobml actien agafnst a wide range C4gram-positive and
gram nagatkre bacMfa. Tegather they provide ccsnprahensive
therapy agafnst these organisms responsible for most supa!fiiial
bacterial fnfacfierss.
~
Nystatin-Nacmycin Suifate-lliostreptenTriamcbmfena Acetenkfe Cream is indwtad in the management
of darmatofegk c%order’a h degs and cats, characterize
by
inflammation and d~ or exudative demratitk, particufarty those
CSUS4 wnrpficated or threatenad by bacterial or candidal
(Candida atrkans) krfectiens. It k also G4value in eczematous
demsatitis; mntacf dermafiik. and sabenheic dermatitis, and as
an adjund fn the Iraatmenf ef damsatffii due to parasftii
iniestatbn.
~
Nystatin-Neemycin SuffataTfrioslrepten-Trfamclnolefre Acaterdde Cream afrould “ot k
epthalmbalty
used
~
Nystatin-Nacmyckr Sutfata-ThieatreptonTriamcinofene lwatenida Cream k incJmtej for “se in @s
cats onfy. Not for use in anlmafa tiich are raised fer feed.
a~
Absorption of tr?amcinofc+seacetcmide thrcugh tcpical appficatico
and by ficking may eccur. Therefore animals should be obsetved
c!aefy {w signs of pdydiiia,
pofyurfa, and inueased weight
gain parliculady when the ~eparatien Is used wer farge areas w
for etiendad ma
d time.
Cfin!cal and mpwfrnantsf data have damgnstiatad that
atimsteroids
adminislared oralfy cf by in@tien to animals may
Indwe the first stage ef parfun?ien K used durhg the tast
trimester of pregnancy and may pracipiiate premature parturition
followed by dyatocia, fetal death, retained pfacanta and metritk.
Additionally, corticoatemtis adminiatemd 10 @s, fab4ts and
redants during pregnancy have raaufted in daft pa!ate in
offspring. C@costertis
admiiistemd to dogs during pragnancy
have also resufted in other congenital anemafies including
deformed forelegs, ph-efii
and anasara.
~
Nystatin-Nearnycin Suffat=TtsiireptonTriamcinefene Acatcflide Cream is not intended for the treatment
of deep abscesses or deso seated rnfeclem SLM as
krffammatiar of the ~phatic
vessels. Parenleral antibiotic
therapy Is k-rdiitad in these Infecticms.
Nystatii-Nwrnycin
Suffate-llrbstraptcm-Triamcinolcme
Acatonida
Cream has bean eslremefy waft tobwatad. Tha eccurrerwe of
systemic reactions k rarefy a preblam with topkal administraticm
.
,..
.
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-..
Sensitiiify 10 naomycin may eccur. If redness, irritation or
swallii
persists or increases, discontinue use. 00 not use H pus
is present since [he drug may anew the rnfaclicm to spresd.
Avo!d ingestffn. Oral er pamnteral u% of coflicoaieroids,
depending on dose, duratii
and specific steroids, may result in
inhibd”m of andcgenous steroid pmducli-cn following drug
withdrawal.
SIDF FFFFCIS. . SAP and SGPT (ALT) enzyme elevatkm,
pdydipsia and p+uria
hava ecwrrad following parenteral or
syatamfc use of synthetic cettiisterolds
in dogs. Vomiting and
diarrhea (eccasienally blwdy) have bean observed in degs.
Cushing’s syndrome in dogs has bean reported in association
with prolonged er repaatad steroid therapy.
~
Frequency of adminiatratkm
is dependent on the saverity of the ccmdtion. Fer mild
inflammation, appficatii
may range from 01F33daily to once a
Suffat&
waafc for severe conditions Nystatin-Nacmydn
Thiostrepton-Tdamcfnolona
Acetenide Cream maybe appliad as
oftem as 2 to 3 times dally, il necessary. Fraquency of traaiment
may be decreased as Imprcwamant cccurs.
Ciaan affected areas, remwing any encrusted discharge 01
exudate. Appfy Nystatin-Naomycin Suffate-ThiostreptcnTriamcinolcma Acatonide Cream spadngiy in a thin film.
klmf
sfJwLJEQJ . Nystatin-Neomycin Suffate-Thiostreptom
Triamcinolcne Acetonide Cream is auppliad in 7.5 gram and 15
gram tubas.
April 1999
Mamdacturad by
Mad-Phamrez
Inc.
Pomona, CA 91767
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