CENTER FOR DRUG EVALUATION ANDRESEARCH

APPLICATIONNUMBER:

21-918

CHEMISTRY REVIEW(S)

,....,~f"!I -,.. _..' -r

NDA21-918

.:'; , ...~~1 I ~. __ .1

CETRAXALI) (ciproOoxaciD otic solution),.0.2%

-HCI

-HJO

Laboratorios SALVAT, SeA.

DivIsIon ofAad-lafectiYe and Ophtbalmolol)' DruaProducts

MIIt.DJ. Sioau, Pb. D.ONDQAPn-Marketial Assessment DtrisIOD D BraJIch IV

_.. .' '.f __'.,:::.~.,.:••',.~.'••""~_"••~•••••..••....•..

.... - . - '.' . . .. ~..",.~~.·::.::..:.f..:.:..•_·.·__c.,;;.·~H~KMli.ii'·'iiiioi'iiiooi"f;;,;,;KiiioiOoy....REV..oloIBl!iioooW...·. __---";;'O';;..j. . . . .....:..- :......--.~-.-' .~.. .,.... .- -~ -~ r'

Table of Contents

Table oIC · ,I , 11 1.•.• ' •.• ,111 2·

c~ RevIew DatIl Slaeet.••••••••.lil •••••••••.•••••••••••••• 'i.~•••_ 3

n. beeadYe S•••arJ' , i ••••••••_ 7I. RKOIIIIII _1

A.~_~ C)Il~ _._._ _ •.-.7

B. .Rec "'-4~e.-i"""Aar--dI,".RiskMrnlrI SIIfI, if~._ _ __ _ _._ ~_•._ _ __ 7

D. S~of~ _ .•..•......_ _.•...•~ __.•...~•._ -....7

A. DeIeri,tillft of.. Drua PwocIucI(s)'" DruI SIl~..noe(l)_.-.--.~.-.-.-..-.-..-.._-._ - 7B. 0."""ofltow thI DNa PIe.. is .....lIId to hiu.L ..._.__ _ 7C. ......~ Of 1'rkJt-AppIU¥IlIa.D••' ........_••••••__•__.mm._. __._.._1

0'1. AcIIn _••••••_ _••_•••••••••.__._•••••••••••••••••••_•••••••••••••••••••__•••10A. Itevii ·sSf_.1 I~_ ••.••••••...- III.I I _ ' __ _ I ..~_.__ ~~__._ _.10B. En.a BIock.•••__.._._._ _.__•••_.._. ._•••__._._•••_ __• •__.._.. 1"0

C. ex:~ _ _ _ _._ _ __ _._ _ _..: _ 10

Claemlstry~ t ••••• iI i ••••••ill••••••••••• i 11

I. bY_ore..-Tee"'"~ (Cfd.,Q)"'" 3.2: ..,or0.. 11S .00SUISl'.AI'(:&~ fI...-r) _.-- ·" - 11p I)ROO.~ ("'-,~ :r..). _ _ __ - - __ '11

A _ •••_ •••_.••••__ _ _ _••_ -. _._ _ __•••.• 16

R ItIGIC)trfAL N

·_:.;n:· .. ;CftIMl.nRYMVlIW .ChcnIistry IWY..0...

Chemistry Review Data Sheet1. NDA 21-918

2. REVIIW#: 3

3. REVIEW DATE: April 17, 2009

4. ItEVlEWD: MiItoaJ. Sloan; ""D.

s. PREVIOUS DOCUMENTS:.,.--0ri1iMlAnMncIM-(BZ)M.a"_t(BZ)AIn.""(BZ)Ame8cIIIIat (Bl.)~(BC)

~.t(AZ)

Amat...(IZ)Am••-(BZ)Am.....(BC)Amal_..(IC)

6. SUBMISSJON(S) BIING REVllWED:

$ t .i.ii1f',,,,,,~.(BC)

Anaat..... (8C)AlDaMaIRt(.-mai1)Am.....(BC)

"'0113

b __

~JUN..200SOJ.AUG-200S2S-AUG-200S06-SEP..200S»MAR·20062"'MAR-20063'.ocr-Zoo,1CJ.DEC..2001J'·JAN-2009B-JAN..200902-MAR·2009.

Pan..._:u.~200902·AJII..200902.~2009lG-Aflt-2G09

_.j~f:.:·,_·.. ·~C~H~ltMIS""""'~~t~KY~··~oiiiiioo·..~..•...~' ' __.·.·~,'.

,....r" j;&- _ •. 1 !

. "

CII.IMtI."Y,MVRW.. ?-'~' ,.p.'I"'n_:r" lit- _ .._ ...ChaItiIUy....DItIa SIteIt

16. CHEMICAL NAME, STRUcnJRAL FORMULA, MOLECULARfORMULA, MOLECULAR WEIGHT:

·tta••Moll..I.'''' CI7Ht~

~.MuI:)"'.12

11. RELATED!SUPPOltTING DOCUMENTS:

Ad"_

I AGIiGft fClIdD fWDMF T....:• ..:. 'ucLOIMr · ""' DMf _ 111:2-T".10Mf3- ., ....4-..· · n' , ...J - Aulln*, dil .....,-..._Pl..".,., -c-.EIII•••li ....-C. '11-'

REVIEW

b(4)

zMlql.-'~ erN/A~ is ............ ." .... thcrctbIe the DMf dktnotMld."~

.. OdMr"...as:

11. STAnJS:

.. .....•.~ "." '. ttl· e

RaATU dCOMMlNDATION DAD

·it . ........19. ORDIIl Of uymw (000 Only) NlA

"'0121

The Chemistry Review for NDA 21-918

L .......adatIo••

A. ......dado. IIlClCOIIChIGoa..App......-,

This~. is NCOIIIftIOIIded for an !lPl'ftWaI-- fiom Chcmimy.~·_Contl'Ols.

......................... (hst-MuIldIII)CO. ~...,orItIIII~......Steps,lfAppNYaIIIe .N/A .

n. S...." ofCIIeIDIatr7 J\SIeI.......A. ••u................-.et(.) 11(.)

Ciproftoucill is .·1JIdMdc fhIoIoquiDoIoM with sp."~ aaci¥ity.It is. wel..........GOIIIfMJU8d ..... is , y. cnUY. Uld tepicaIIy to...vaMly ofiafeaCioa 1be primary 0' of fIuoruquineIaMs is:_II.:&.:.:- f.a.- ............ 'ft- :-a.. .• :-..:a.:.....&.-~_I_o--..ur-cnzynw. a.-.e~........_ ... ., . VI........aeids. 1'hI~ .......~CETRAXALe/..:-a--:-otic.. .P~ -~ .. . ~~soIutioII) • .1% is le_, co.....,~ ".IIn 01QiprotloMeiah~for EMh 2'ntLof. soIutionoquiftllatto 0.$0 ofci~ in.GdM ........ pov ....,_.- for injection. SocIiuIIt ..,.. ......, to pH. CipndloxMinisav ~.....)'611I ., 6- ,. 4 '-{I.-..,.,..).~)'IielCid. Its is: CI1HtafN,o,.uewtA............. islIJ.ft.

......... ol~iIIll~is:

"70123

~.

ttJill~li.

II.J

J!.·.I

.'!.·.

I,Jl··

~.I.li

i.I..·f.·

n...

1~.··.

l~!f

l~~.IIP..

".n

>.1

'f

..It

-ir'

-[I

t."

>11

I

11...1 '1'.

~<

1.11'1

f."1

'.•

...(.'.

"1.''1

I~iI

't.c

:iI.

'.'1

1.

·5

>.I.

·0'I~

s[I

~&

I~-

....•

1~III~,l.

tr{i"lh·~r.I·.r

~~.t:.

:.~

Itllf

'f.lllrJ

J.~,I.

fl~l..~t-

i:~!'~

.·.jt!

!ill~:

i}il

[11Igl·

~I~t:f

!I~.

~r1f

,,1.riol

b;.~I

I...Q

oI!.

..!.

It~

f,::

inf

!t'll

•.I

..

..df

l·J!il.

i l.J!li

-t:I·.··i

.·.nt.n

f§....~I~

H..J~

II!i.~

il'a"

-.'!I.

.'£~~..

IJ"IJJ

O\Jri

~I".

~nh

Ifa.

.!;.!

I~I..

~.~I

I'l":

111'1

'1"'11

f§

~J'~.'

f~E

I·i~'I

:iI:

II."I

I·t:$tJ

It~·

IJiU

~·fthiltt~r!1

ttlli

hif

..r.

f..r

~.d

Ias

·"I

_0

J~.

II.

lIII"

q..

1ft

,w

_'!"

'"fl.

..

0-~ .....

..cr~ -

er ~ -

I,,~rlll

I:i~,I

fll;,I

l!"(~n,

l·lli'

(,t.U

Uf.I',

\Iii

.I(J1

IllllJ

1liI

slltil~

till\

tin

!~l

l~~

III',·~,

tJtJI

II!t

l'I

~:~~

l~!Itt

l-.

(I

I'"

rw

i-,

w<

ls.I:

.8'f

:I.

,'.'fl

wII

]-II

-'M1-

1'I:~_

-:-'t

.1~

J•

_II

't

I'

,iFI•

•It

1'1a

_Sfg

'=1

1'111

"I:'I'

,Is~I.

!fl"

'-w

,W

1"1"1111

1 lfi,

!!jn!I

Jiilli

lln~

I11~

i!J[I[

IH1;

~III

!r~.

t~8'

r~ll~

fl~!llf

11

&,'

l!tl

,

rr··i~

ilflll

1fi1

ilil!

IJn~

·IH

~H't

lrrI

rf

,',',

"''

"'i~

It..,.

,'rr'

ii"I.',

\r:r

lIi$

,-'

"II:

:'-

'J

•'iii'"

J-

,.,

c:r~ -

=r - .:e

a -:;: -

c:r~ -

....ioaaI~fOl'''' faaished .... pIOduct.14 ...36 IIlO8ths for 14ceun&prll 11.... 1'huaultlof., . - _ }COIIIpOUBdstbr tt.. b(4)NGOIIIIIlCIMW expiry ofdie ~ sIIouhI COIdifm RJU&iM lftOftieoriDl is DOC-*y. s.tiIr.tory ovwall ~ omc. ofColllpl__lias belli issued the_....... The quality Micm.mow COIUUItNCOIftIIlCIIds appnwaI.

m. AthdIdstntive

...............11

Chemise: Mia.. J. Sto.l, Ph.D. 0.: April I?, 2009ChInIistry....Chief. NonnIII R. SChn"l«, ""1). 0.:,..Mu.SIS. s-ita s...ta, M.D. 0.:

C. CC:S....-sIPMMolediftlNlMO~. ..

SIoInMIa.

,.IOel'D

/3 Page(s) Withheld

__/_ Trade Secret / Confidential (b4)

__ Draft Labeling (b4)

__ Draft Labeling (b5)

__ Deliberative Process (b5)

Withheld Track Number: Chemistry-_'_

................. ., __...., .......... ,... .....II

Ifil'.. .1...../2./200' 12:25:50 1MCRlMIS"l'-......1 reee•••e4

......e...."/21/200' 12:1":S' PMeJIIMII1'