1. No category

*
.
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
,,.
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.
..
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.
-.
Freedom of Information
Page 3
Attachment:
Summw
Generic and pioneer labeling
Generic –
Pioneer –
. . .
.~.’.
..
.
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
.
,..
.
.“
-..
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
,.
‘
,.
---—-—-—
. .. —..
—. . .
..—.—--.——
..
R13w?lb-m+.
.
f4xr331m3A34-- . .
dWlW4
WWkD’J 3384
---------------
1
..
-.
—
-
--------
“ANO SIKI ON
SxKJtmmllww)lnfn
-uwes’mwns!%lmm
Daw4E01/@Iv :-ml
ICml
“WmwJJi m m-titi
‘mmiwmu IOato
alwzmcd
‘mmmxlu @4a ‘umwJm
Wm ‘m 341’JW.q31urqm
‘WWP !MWJil ‘wlPlm IWm
‘=40 WAaoJe ‘WeMkmti
Wm@nmU
WJqqWpfJj
$W.W%W4P ‘OZ-WO=W
IPJ8)Im$m Im4m?llm CSw
Uml$ Cqqqlm SncelmUcIJ
H1 31
Mu
“k/L g
~ ~,..
-1--..”
. . . . . . ...-%
-Iw,l
qmm.-..-.....--.....umwm~
m
Sz--w%q
wummo~W’rA!r&
!I
m wwt-’-’’’’’”’-”-’”’’”””””-w*
:Smlml URfl W?43
-------
vWAdc=J33W
MM%’WS ~
aN3dw
4
-
,.
,,
.*
I
t
1
1
1
1
1
:
I
I
1
1
I
:
1
I
1
I
I
1
6 g 1 :~N31Nw
I
EN
wn4mww0z#wV?w
L9L[ 6 V2 ‘VNOLNOd
“2NI
~cuuXdWXVHd-CHW
iMPWJKJu Dio BPJoa4w
@ Wl%lj%lmwwl
my pmpy :llq~
(UIO*12 Oplualtsv Ouo(oulauloll
-uOld*iirOlui-9
i0ilnS U154U00N.ullDIIAN
wv3kia
Ill13Awwlf3a
Jo
!
,;, . . .
.. . .
%.
.,.
:.:.
-,,t..,y
,.,.
,.,
,,.,.,..,,:,.
.
...........
$+~,ijj:j.;!:!~~
,.,...
;.Ji ,,...
~
~j”’&,:+
$
,,1
J@+<t ,,
“ ‘
:A\,~:,y~,.
(&.:\\jy~::.:
..
.,,.:
:>;;
.,,.,.
.,y..
——
‘
..,,
,.,
.;
......
,,““;;;;;;;
.,,.
....... ,.
. .....
,,. ,
!.
,.,’
,..
.-
,.
..;
-
.
.—..-.——-...
>.
4
eloPuWIV
,,
Y,
;$
,,
.z.
“.~~
E
,%
,.,.:,
..,.
,.>:
:.:,
.,,
,,
z
—...y.
.. . .
~zob.br
Vsn U! PaY-J!Jd
W6 L Aw www
OZ1!X NkV ‘s@!aH
‘“3UI ‘L#leaH
Joj
leU.J!UV
fzoiw
——.
‘Alleo!wleq]qdo
Aqpama~ejnuew
aq
‘uo!leJ]s!u!wJpe @$!dol ~l!M
UJalqOJd e AlaJeJs! sUo!]oeaJ o!wa]sAs )0 a3uaJJn330
paleJalo] !laM AlauzaJlxa uaaq seq ueaJ~ 13qoued
—
.. .
... .. .... .
*P---------
.-.
-..
-
. . . ..
—
. . . . . . . . . ..-.
.__..
a.zob”w
azotw-
AVAII)S
‘H“q
0PS80fN ‘UW~U!Jd‘“WI‘SUOsq qq!nbs
IIII1I
‘Saqnl
UJwfis
Ipue weJ6 S“L u! pa!lddns
s! (UJeaJ~ ap!uola3v aUOIOU!XJJe!J~UO\daJISO!~
.ale)lns u!3AuJoaN-u!)elsAN) LueaJ~ 5oloued
L1311ddflSMOH
‘Uq!j
u!ql e u! A@!Jeds tuea~~ 6010Ued Alddv ‘alepnxa JO
15Jeq3s!p pa]snJ3ua Aue 6u!AowaJ ‘seaJe pa13a~e ueal~
smmo ]UaUJaAOJdWl se paseaJ3ap aq Aew wau4eaJl
)0 AwanbaJ~ ‘hessaoau ~! ‘Al!ep saI.u!l c 01 z se uat~o
se pa!ldde aq Aew weaJQ 6oloued SUO!I!PUOOaJahas Jo~
$aaM e awo 01 Al!ep aouo WOJJa6ueJ Aew uo!le~!ldde
‘SUO!WIJUJPIJU!pl!uJ Ioj wo!I!puo3 aq] JO h!JaAas
aqj uo
]uapuadaps! uo!leJlstu!wpe /0 hanbaJj
NOllVHISINIWtlV aNv 39vsaa
AdeJaqi p!oJa]s pa]eadaJ JO pa6uoloJd qt!A4 uo!le!sosse
u! pauOdaJ uaaq Seq stop u! aUJOJpUASS,BU!qSn~
‘s60p
u! pa~asqo uaaq aAeq (Apoolq Alleuo!seno] eaq]Je!p
pue fIu!I!uJoA s60p u! sp!oJa]soo!uo3 o!laqluAs JO asn
o!wa$As JO leJaluaJed 6U!MOIIOJ paJJnXto aAeq e!JnApd
pue e!sd!pAlod ‘suo!leAala aukua (LIv) ldgs pue dvs
suo!va~u! asaql
UI pale3!pu! SI AdeJaLp O!lo!q!lue leJaluaJed ‘slassaA
~!]e~dtil
aW )0 uo!]ewuel;u!
se yms suo!]oa)u! pajeas
-daap JO Sassaosqe daap }0 kIaauleaJJ aql Jo~ papualu!
IOU s! (weaJ~ ap!uo]am,i auolou!2we!J~uolda4
so!ql
-a]eJ/ns U!3AUJOaN-U!]?lSAN) weaJ~ 6oloued
pasn aq IOU ppoqs weaJ~ 5oloued
SNO11VOI(INIVIJLN03 Aoeo!/~a alqepuadap JO a!lo!q!we IefiunJllue PaleJalol
.llaM ISJ!I aws! U!lelSAN leaq 01 pau!wJad aJe suo}sal
pue %p!sqns ApdwoJd snJ!JnJd pueewapa‘uo!jewwel~ul
wo!~eJls!u!wpe Ieo!dol uo la!iaJ 3!leUoldwAs
Pa6UO(Od pUe p!deJ 6u{p!AOJd P\OJalS031\JOl 3uaWuAS
auolouwe!ji
‘leljal~ewe
wa]od es! ap!uola~e
pue le6un~!]ue ‘3!l!JnJd!v.Je “tiolewwelju!-lwe
:s]]aj}a
3!madeJaql o!seq mo] sapmold lweaJ~ ap!uoialtj
auoloU!2We!J1-UO] daJISOlq -ale)lfls u12AWOaNwllelsANJ
weaJ~ 6oloued ‘swa!paJ“{ UI aA!\3e J170) SII )0 afllJIA Ag
SNO113V
vo!ielsa)u!
3!]! SeJed O] anp s!l!lewJap JO
]uawleaJ] aql u! wnfpe ue se pue :s!l!lewJap 3!aqJJoqas
pue s!]!] ewJap ]oeluoo ‘s!l!lawJap Snolewazoa
u! anleh JO osles! II suo!]3ap!
(wwe
wowo) lep!pue2 JO
\e!JaDeq Aq paua\eaJql JO ‘pale3!lduo3
‘pasne3 asoq] AIJelfl!J!]Jed ‘s!]! ]ewJap
aA!lepnxa JO AJp pue uo!lewwelp!
Aq paz!Ja]oeJeqo ‘s]eo pue s60p UI
sJapJos!p 3!6010]ewJap JO luawa6euaw
aq] U! pa~e$!pu!
s! (weaJ~ ap!uo]aov auolou!3we!J~uo]daJ]
so!ql
-a)eJlns u!3AwoaN-u!]elsAN)
weaJ~ 6oloued
SNOWNONI
‘suo!]ta~u! le!Ja]seq le!3!/Jadns ISOW JOJ alq!suodsaJ
sws!ue6Jo asoql lsu!e6e AdeJaql a.h!suaqaJdluo3 ap!AOJd
Aaql Jaq@o~ “e!Ja]3eq aA!]e6au-weJ6 pue aA!]!SOd
-UJeJ6 JO a6ueJ ap!m e jsu!e6e uo!ve le!qoJ3!uJ!we
suaxa u!~hoau
:s3!]o!q!we Jaq]o 01 weis!saJ
aJe WJ!qM Auew fiu!pnpu! ‘sws!ue6Jo aA!]!SOd-WeJ6
lSU!e6e Al! A!12e /0 JapJO 146!u e Seq UOldaJ]SO/~1
‘e! Ja13eq ]su!e6e pal!qfqxas! Al!A!13e alqe!3aJdde
ON “slaw!ue 01 o!ua60q]ed !bunj Auew 15u!pnpu!
@zn} ay!l]seaA pue ]seaA )0 ka!JeA e vsu!e6e OJ//A
~!lels!6un\s!
u!lewAN (e!i!uo~) sumw wfw
suo!]oaju! snoauemo /0 waw]eaJ] aq] Joj
SNOllflV33tld
‘e2Jeseue pue e!la~oooqd
MalaJo) patuJo~ap 6u!pnpu! sa!lewoue lej!ua6u02
Jaqlo u! pallnsaJ osle am~ Aweu6aJd 6u!Jnp s60p
0] paJaw!u!wpe sp!oJa]so2!lJo ~ fh!,ds),ou!
a]eied ijap
u! palpIsaJ aAeq A2ueu6aJd u!Jnp sluapoJ pue sl!qqeJ
‘s80p 01 paJals!u!wpe sp~oJa]soo~poo ‘A~leuo!]!ppv
auo31qjawls
pue p!oe 3!qJos ‘a]eJealsouow
I03A16 aualAtoaAlod
‘a]eJea]souow @a3A16 ‘wm]e/oJlad a]lqM p!3e 31JI13
‘aleJ]!3 wmpos ‘ap!xo!p wn!uei!i ‘UOITUOSlo\!qJos ‘I03A16
aualAdoJd ‘uaqeJedlAdoJd ‘uaqeJedlAqlauJ ‘aP!JOpl~oJPAq
au!we!pauak4qla
‘OZ-q]aJea]a3 (puej loqo3te lAJea]a3
aseq u.teaJ36u!qs!ueA 6u!ie]!JJ!uou ‘snoanbe U? UI
q]!M
6W 0“[
““””””’”’’’’”’’”’’’’’’”’’’’’””””” aplUO]a3e
ooo’ofj~
~~~~~~~~~~~~~~~~~
~~ ~~~~~~~~
,sule]um
Aqpasnes
sle~
uJeaqj
ap!uolaqj
auolou!3we!J1-uoldaJJso!
ALIVNIWHA
‘aw!l }0 spo!Jad
papualxa JOJJO seaJe a6Jel Jaho pasns! uo!leJedaJd aq~
uaqm AIJelna!ved ‘u~e6 @!aM paseaJ3u! pue e!JnAlod
‘e!sd!pAlod JO SU6!S Jo~ Alasolo paAJasqo aq plnoqs
Slew!ue aJo}aJaqL ‘mm Aew 6u!qo!I Aq pue uo!leo!ldde
Ieo!do] q5noJ~ ap!uolaae auolou!wue!Jl JO uo!ldJosqv
aUOIOUIXUelJ:
s]!un ooq’z “ ““”””
““’”’””””’””’”
“ uoldallso[ql
aseq unAwoau
Ihq’z
““”” ““’””’’’’”’”’”’’”’” “’’”’’””’’”’”””
IUatehmba a]e~lns u!]hoa(;
si!un
o!
u\]e]sAu
wejb
q3e;
“apwo]aoe auolou!otue’!l] pue “uo]daj]sol~l
‘a]e~lns u!oAwoau ‘u!le]sAu Sau!qwoo weaJ~ 5oIoc?d
NOlldlH3S30
u!
“s!l!Jww pue e]uaoeld pau!e]aJ ‘q]eap lela~
‘e!oolsAp Aq paMoIIo~ uo!l!mued aJniewaJd ale]!d!oa~d
Aew pue hueu6ad
JO Jalsaw!Jl lsel aq] 6u!Jnp
pasn )! uoJJ!JnlJed }0 a6els lsJ!~ aqj ampu! Aew s[ew!ue
OJ UO!]3alU! Aq JO AlleJo paJa]S!U!UJpe Sp!OJa]SOLl!]J03
leq] paleJlsuouJap aAeq elep [eJUaW!JadXa pue leo!u!l~
sm4J33als
“jeMeJp~]fM L%JP 6u!MOjI0/ uo!]2flpOJd p!OJa]S
snouabopua JO uo!l!q!qu! u! llnsaJ Aew ‘p!oJals o!J!3ads
pue uo!]eJnp ‘asop uo fiu!puadap ~sp!oJa]soo!Uoo
JOasn \eJaluaJed 10 leJO wo!lsa6u! p!oAv
“peaJds 01 uo!loa~u!
aqi moile AeuJ 6nJp aql aou!s wasa}ds! snd $! asn 10U
ou “asn anu!luo3s!p ‘SaSeaJW! JO s]s!sJad 6U!llaMS JO
uo!lel!JJ! ‘SSaupaJ JI “Jnmo Aew u!oAwtoau 01 h!h!\!SUaS
ql-aJe41n
pue s600 uo asn Ieoldol
Joj
S u!3hLJoaN-u!lewiN
lAIVEllK) (@070NVd
1[11
wepeupkwh
pasuem[
e JO.sep~o aq] uo JO Aq asn OJ Einlp sw WJplsiu Mel leJaPa+ :NOIHIKI
‘pooj JOj pasplJ aJe lp!l+vl slew!ue u! asn JOJ10N ‘AIUO
S\eo pue s60p u! asn JO) pala3!pU!s! weaJ~ 6010Ued
3zob-PP
S9NINWM
E_-
:!$:..(,.;