CENTER FOR DRUG EV ALUA TION AND
`RESEARCH
`
`APPLICATION NUMBER:
`21-660
`
`ADMINISTRATIVE DOCUMENTS
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 10 16, p.O I of 102
`
`

`

`American BioScience, Inc.
`
`N21660
`
`:
`
`,\Il1Cm:.11l BioScicIlCL', IIlL,
`
`PateDt Certification
`
`Paragraph If Cer1ification
`
`In the opinion wid tv Ihc best knowledge of American BioScience, Inc., there are no
`
`unexpired patems u~~a claim the listed drug [Taxol® (paclitaxcl) Injection] referred to
`
`in this applicmiul1 Hr that claim a use of the listed drug.
`
`Mitchall G. Ciarl:
`
`Vice Presidenl, !~\:~' Clj:llOry Affairs
`
`Date
`
`2730 Wibhire 8Inl ... ',~ :t 110 Salli. Monica, California ~J Tel: (JIO)88J..I300 "'n: (JIO)998-MS3
`
`3
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 101 6, p.02 of 102
`
`

`

`American BioScience, Inc.
`
`N21660
`
`Dep,ortment ofHealll'land Iluman SeMces
`Food _ Drug Administnltion
`PATENT INFORMATION SUBMlnEO WITH THE
`FILING OF AN NDA, AMENDMENT, OR SUPPLEMENT
`For E.ch Patent Th. t Cla/m$ • Drug S~htnce
`(Active '''~ditnt), Drug Product (FomtUl.Uon . " d
`Compo$it/on) . " CVor Method of Use
`
`.... -
`
`Form~: OMS Ho.0II11)..O!i13
`~Ion Dale: 07ll1M
`S- 01.18 ~O'IP.3.
`
`21-U0
`_OF APf'UCAHT 1_ HOUlER
`American B ioScicncc. Inc.
`
`Th. tonowlnQ Is provided In ICCom.nc. wtrh S.ctlon 505(IIJ I nd (eJ 01 1M F.a..1 Food, DluQ, Ind COmI.U.: Ac t
`TAAllE tw.IE (OR PROPOSED T~ IoWoEI
`AbfVIl1cTM (lJQb Pat li taxcl) for rnjKUb!c Swpmsion
`
`ACTIVE INGFU:Ole N ,
`
`Pu;litaxci
`
`I ~~~~~S)
`100 mgfYial
`
`005.A.GE FORloil
`Ste,ile powder for injectable suspension
`
`to be submitled to tile Food artd Drug Adminisn\iGn eFDA) with an NOA ~CI~on.
`This ~ent dedalillian form is required
`"mendn-.l.. orMJf>lllemenlu l1Iquired by 21 CFR 31 4.53 II !he _
`.... ~ in 21 eFR 31 • . 53(11)(4)
`Within IhirTy (30) cIay$ afler wp"~. (I a n NOA or 'lIPplemen~ or wittoirI INrty (30) days (I In u.nc:e or • ' - paten\. • now patent
`~tIO'I musl be submitted "'"atnl 10 21 eFR 314.531c}(2)(iI) willi .11 01 IIIc fequifed inIonnf,tIon boiled on the .ppro>red NOA
`0/ ..uppIemenl The information IUbmittod in tho decla"t;on Ion-n IUbmitted upon or .ftef approval .... be the only irtformat)on relied
`
`_n by FOA. ~ bling • fI"Ient In 1he o.a~ BooII.
`
`For hl.nd-.itten or typewrite . .. .. Ion. lo nlyl of th! • ... port: If additional space Is raqund for . ny namlille In$wer (I.e .. one
`that dUll not require a "Yu' 0' "No" response), please 811l1d'1 an addition!1 page referenci!lg the question number.
`
`FDA wfII no! list p.renl Intotm.tion It YO" nla .n Incomplele p"lan! dacl.ralion or tha ,..tenl I1lc'.,,1ion fltdlcalal thl
`P"laIII Is nOI.'IQ'~ for Usfing.
`
`For uch p.ten, 1"""'/,,,,"11 fty Ih. pl"rling NDA, • ...-",ltIt or l"f'Pl"m"nt ~ad I """', """ ",,, .. • "bMlt ai/ thl
`Inform.tion ductftnd below. 'f you .ra "'" slIbmi!Ung .,.,.. ,..tantl for Ihl$ ~ HDA. a",end",lnt Of" IlIppI_nt
`~ .Ia .boYl .""f/on and ..... _ . 5 . n<l 1.
`1. GENERAL
`I. u.1tacI SIll .. Pal ..... !-lumbar
`6.~)7.S79
`d 14 ...... of P ..... o-.e.
`Americl11 BioScience. Inc
`
`'. ' .'
`
`Co e"P"'jjo~ ~. oIP.""
`21221201l
`
`b. IsIUl D .. a .. PlOIenl
`)12SI200J
`.todd .... (01 P_ o..n..:t
`2730 Wi lsh;,e Boulevnd, Suite 110
`
`C4yISI.lIO
`Santa Monica, CA
`
`,.""
`
`9(40)
`
`TelI!pIIo .. .... '""bef
`lIOII) 1)00
`
`FA,I(N_ (l~1
`)1099"5.9
`E ..... &I_ ... I ( I_ I
`
`"""'''''' (oI"f1M1"' __ '~_'" I ••. ,
`
`• plaGOI 01_ ..... 1_ u.. Unllecl St.tH -....w.d I<>
`
`•. 14m' '" ....... 9' 'EI!!!!S!'!!!!"" """" __ Of ............
`,KeJye notIoe .. pa1«JI cart:llcalion undef . -
`$O$(b)(3)lnd ~)(2)(8) oltha Fede .. food. ONg,.nd
`
`, Of t;Q.to. app,"",nVllolder - . fOOl leIich Of 1>1 ... I
`_
`pIIoo olbutin ... "';1II"1~' Uniltod SiMas)
`
`.p)lfOwtd NDAOI $tp~Of1I ~le<tnaod ~7
`
`dOle a ...... expl.-a!ion daI.?
`
`fORM fDA 3s.62. (7/03)
`
`Cosmetic ...,. and 21 CfR31 • . »""" 31'.H{dpalo ne
`0- N,.
`, I>IIIe p .... <l1..t ... _ . - . ~al\lIllOl " ' ._ ._tod ~ \o,lIot
`• II Ill< pol"", f.ra,""".., abOve h .. been ....... _ ~ 10.- 1ioIr,g. is 110. ~.~ ....
`
`CcylSt.e
`
`2JPCoda
`
`T,leploone N\I"I\ber
`
`fA,K NumDa'(If<fVII_J
`
`I tAoIlil A<l<lfIIS (~_J
`
`O'M
`0,.
`
`181",
`0",
`
`22
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 1016, p.03 of 102
`
`

`

`American BioScience, Inc.
`
`N21660
`
`FQT fII' plttnt "'trWlCtd R_, pnwldt "" toIlowIfIfIlnfomrl1tfJn 0/1 :III. drug '"DS",~., rInIfI pnxIuct.,rI/or m.lllod Qf
`
`us. tb., f. "" .ubjtet of til. pllldfttg NDA. amendm"'~ IN 'upp/Mlwrt
`., Do8I h ~I d&i'n u.. <IN; ._ 11111 ~ !he _
`l.D1"1I ~~.Ml~ tng~"I}'
`
`ir\9IWie<rt in IIHI ~ PfOCIud
`__ Inlll.pending t«),O" aone_ ...... Of~?
`u DoH 1M ~MO .ot_ '
`''I\.IIIIIIISIa/a _It.""""", ~<1IIIII_
`IngredIt",do.Cf1bed In tile pe<>djnIjI-' ~ <If . ~"'7
`
`. " r
`
`n·· ~ ;·
`
`tnI ct.t.
`U Wlhe _""IO~ 2.21t -Yt.:dc>I""'<:e<It\' 1Ml .. ~- II .. 1IedIftIiooI, you _
`• <Jrvg prod.ot contHII"" IIHI ~ ..a perlO<m h 1l1li1 II ij,e drug "",",uC!
`domor-.tr.tng _
`~ In Ihe MDA1 n.. Jypeortesl_ fIII"ired ill ~ IIZ1 CfR 314.S'lb~
`Spedfy !hoi poIwmotp/lic Ioom(.) claimed tr, "'. p8WlllOI_ you _
`thaI .... ",WI"
`
`U.
`
`U
`
`0,"
`' ',' .! ..
`0,.
`0,.
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`0,_
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`pO(" r>I n ...... 1 (An ..,._ ~ required onIylllhe PIle'" 10 • ~-1>1~ ........ )
`' .
`" . , .~- ~,: \~.
`" ,
`'. :.
`4. _!hod of UM
`<;IaJtrzrn, • "'_ " of using __ .".", dnIO
`SponSOla mllsr slII>m1l ",. 1nIo",,0ii0n In HCIIon 4 ...,..,. lor MC~ palenr _
`pnMIue1 rorOlftlc" ~b booIlIg_gflt fo,_ moCl'>od oIu ... dI/In " ,_, , , , . ._ . , . . - - ,_,
`lhe I>"'~nl cia ... .,..,. or ....... mol""", d .... kif ..... 1dI_1 io W"" I<IU\JIIIII>
`0'~ 0"
`1/1. poo ... ing NDI\.. om .... m""'- .... ~.",1
`U Pale'" CI ..... """"be, (es bled .. ". PI/IIlll 1 [Iou !he ,,"lem dain ",Ietwad iI U clain • pending IIIIIhad
`1-6, Io-H, U·27, )0-42, 49·~ 1
`0I11H kIf'/lt.k:!l JWfQVJI b ~og .cugN h 1tIep«'41'1!i1 ~.
`_~... 1tment7
`Y ..
`
`.-
`0, _
`
`0'_
`
`0,_
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`.'"
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`lSi ..
`
`lSi ..
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`0 "
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`0,.
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`0,.
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`lSi ..
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`lSi ..
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`0 ..
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`. ~ - " ..
`lSi ..
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`n ••
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`" Doe. \lllpa16M cia ... on/)' .mltabol,,-ot IIHI_ ~~ Intbe _
`or . upp1omanl7
`(Co",Plelt l!>e inIo"",U"tI In .. ctIon 4 below ~ I~e ""len! ciano" • ~ ....tt>od« \ISing IhI pend<->o
`dN9 PfC""'" to acImlNsle< IN .. _cit • . )
`u Doe. u..~.lent ""nonly_" _ I e ?
`u H l/1e ~M6tII ,d.' • ....., in 2.1 iI a ptWuct...,._. ~ It IhI prod<>d. cIa_ in 1M
`p.!e'" _11 (All an._ IS requi~ only IiIIhI ,.terri ill • p-OduCI-I>1_ pOI .... )
`, .
`J.:DNo Pioduct ~eoo,~nfF.O"~fulatrOn)
`,.,
`• tile "",ent clam lhedrug pn>oIuCI. as _ In 21 CfR 314 1.0. IN pording~.
`..,. . ....... otnI. Of • __ ..... ,..,,,
`
`:;"::.t·:
`
`• IhI polen! tbf:n only an Hermec!lale1
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`u
`
`U
`
`11110. paten! reletetICtd .. 3.1 is • ~fO"\oeI-by~CItU pm .. t. 10 1110 produot de-""- ..
`...
`
`-
`
`<
`
`':
`
`f ORM fDA 3S42a (7/03)
`
`Peg. 2-
`,"' __ ... " .. ,_ u
`
`23
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 101 6, p.04 of 102
`
`

`

`American BioScience, Inc .
`
`N21660
`
`• .2. 1I!he ._10 • .2.
`"I'n: identify...,i(/l .peg.
`kty!he IIH """'" rei ... •
`_
`10 "'" p:OPOHd
`~Iing Iof "'" "'"
`
`.... "
`
`Cio"'. n~7. J2.J.4. 39-U. _.~ I -~~p&dit.I..>:ooI) lor 1Rfed_ '~IPI"'1on 10 .. ~1c:Ie ...........
`bound (rIe&) room oIpactIIlXIIl s..~ AbraltaMIo ~ n. ""'ke 10ydow. ,*",Iyophtlzlod ~
`_lorr ___ o.e%$oo:I ..... ~ ~ . U5PI>IIo<Io_ .. IIIfU. Ion. s..~
`E.ch.~ "",,~.i~, loomg dpo.o;il ...... nd ~OOO"'g"'h'.' .. n oJINm ... 8M o.~
`1Ibruan. (nab pacIiI~""'~ .... porIIiorIlo~ Iort. "._ ... oI~ ~uI ... , *. s....
`__ fOf....-_ ........ _("""~ .... ~,..~)IIII._oI260fI'IOi\'II·
`~,.., -...,,_.:)Qmln_....,3_hat_..--lobe 011_. s..~_
`-.w.ntJon. /obf...-lIluppliod .1 . llooriloJrclrhll:uod perwdtrlor _~MIor. ..... s..~ftifd
`-.w._ P/a.Dat1IIicwr Ibr """' .......... ~. ReconaIIIIIe eodl YEI. by ;:,jor<:ting 20 ml 01 0.9% Socii"",
`C~~ 11'4jedion. USP s.. oaaa. _~. ""p&'IIIia'Ilor ~0Wl0Ca~. ElICh mL 01 1M
`_1'I~"'1GP ... lcIolomluIolicnMl""'M&1n5 mgrml~, s....~~Adrnn~Prap ... 1icwr1or
`"'-...,.,,-_.
`Cio"" 30 ·~ne (II8b pedItue~ lor ~ 'UIPIfISIon II 1 .. ~ .......... -Wund ('*'J form 0I~"""
`s.. Due""",,,", Eactr ' ing_ 'IIaI CO_ 100 mg 01 p_ .nII -..m~ IlOO mg 01 h ...... n .lb<.mln.
`s.. o.~lbI. This ro"" ... 1ioft II ".. /ram ooIvenls. s.. De~ All...,. ... (M!> ~od~ .. e/) /oIIrfet:Ul>Ie
`..... , c....,... s.rr _ . "u~nll. " .. mostlmporto'"
`ouspemionlllnclicated ,"' .,.. _ , 01
`tWTIlllolDiic toxdy. _ . d_ ~.nd no lII'....afy ~ r..-.ibIe. Seelldwtw ~ HeIrNJtD/a1ic.
`C<0II'IQPI>0r~ p __ '~1on It ._d 11' ~'. s.. _
`G_.(<500ClIIIIrnm'l~_1n12'llr0lpot;cm\lwlo<lwl/l.o.t>r ...... s..~RNmIN.'
`~1oIogir:. Amonrg pal_ "..,O<! In !lie PIIue 3 mltoslillic bteHl "....,.. &lucIy . ... UI:cp/'I~eGI>I'ItI __
`~ U!ll.lmm' (~4) i'I $'II. 0111>0 pMltnll __ .. ~ of260~' eomPA* 10 22"'11'1 p;IItiefrb; ~
`~,.,..,... • ...... """ ~
`AtI<..-.- don..,. <:<>ntoin~.€l. _.ro ... ~)'PO_ItMIy_io"" 10_ .. _
`......... s..A~
`~ocIions: ~f>,i!y - . (HSRi). F", _.tic btu., COI'ICOt. -..... ... {Mb .,.cIiI1D11or ir'Ijectabk
`ol16c:tift. SHlloP?f end~, Abtuant ;. .... ppIed ... &loNe /twlllliled """"* lot ......... Iit ... ion
`.uSl*'lS .... ) ... cIot.d2GO~·_io1....din~_lOmln.Cooev.yl_qlw-.,_t<>be
`Del .... "a. S .. ~gor _ A_InoIO!; ~ fry _...:>US Admi'Io'lfraIi<:vr. fleconsllh/le.ICI'I ..... by
`injecli<>g 20 ml '" O.~ SocIUn C/'rIOrII5e Injec:tiGft. U$P, s.. ~ _ Admifn'$hflioll: PrwpMItIOr! fryl_,..,..,...
`AdnWriJntio<r
`
`Cloirl 31 • .o.twUlno (~~~ 1Ot~, , .... """'iotrjit. ~fIO\l.'*" liC>\,rr'lo'l·bwno;I Ir>IIIIJ tom'! Or
`~a.o1. S .. Dltsctlp/b'f. Each oIng1o·lIIe"" con"", lOll mg a# .... d.'Inei • ..., ."",o>lrnItoly IlOO mg 01,....,."
`.(b""" ... See o.scriptIor>, rObraxono ('*' poc:ilolool) b iniKt_ .... ~ 10 Jnc:IIw.d lot tI>Il ... wntnt 01
`- .tnm ca".,... SH ~Iion. \rI o-'l tt>e ltaquenqr 1l'1li H¥Orrify of ... uMiogic INIlhitotlont. ......
`~~ In potlo .... receM-Ig l ir'I!lt-ag<InI " " ' -. SM~' RNc/;.,..u: N~ Ponplle.al
`"""o'OP.1hy _ . oto.ervtd ,. 6<1% 01 oIj palionto (10% _e). S .. . . . - ~tcfIMI:~. P..."...'
`"".Iy 1r'I1.,.-'" _,.;u,1n n d.,. of~Abr' __ "11'1'.
`noUfCPIlhy .... Ito. ClrIM 01 A/Ir, .. n. dit(;onIlnualion In IY.l6G (4'4) of .. PII.it01'_ $ .. ~ ,.~:
`~. Sensooy '.,..,plc", .. _
`SM Ad>Iww ~_.:~ . P_""nv __ ...... ~ Inmpt\o<\horapln .... " " ' ._ ....
`r"'AIln ...... u-"". s.. ___ . :~ i'Io_of~.poripI'Iorol_po.IJrolo._
`rtpoMd In the r:ioicoltrlal. s....AmrIIIx~' N~_ OllIe, Ilion ~ ..... mpo.tIr; ........ neu~
`e""nlt lot_nil Abf ..... dnio1iotrolioft hrte t.en ",no « \%) 1M I'll'" W::bIed iIctIomlc WOke. me'.IIlOk.
`on<e!>h'~" conIlllioor. d-'""",,. 1
`1 . . . . . or'ldll'l<>Dd ........ onIdroprn.ion. SMAdIwu~..:tioIu:
`"""'*. Abra><orno (nob l'OeiI_ lot ir>jrocIobio ._nolon/ 01 • doN 01280 mg/m'
`~~ For met •• 1ie _
`. Abr'~ jo IIrPjUcl .... ole" ~!ired ~ lor noconotlMlcn bel""' ..... s.. Du .... etId
`"""' .... lertd ntnrvo.....,.." _. 3C mlrrulw _.,. 3 - - . .... """ II'- tQ be~, $ .. aos.g. end
`_
`AcmfIiS!nlf.Orl.· ~ /01 ~~. ~.ut, NcI'I via' bV Injetting 20 ml of 0_9% Soc!iwn
`C~IoHc:I. l .... ctior'I. USP. SM eos.g. _ -..snr.<on' PnopMaIion lOt /nino"""""" MrmIII1aIiotI.
`
`FORM FOA 354h (11()3)
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 1016, p.05 of [02
`
`24
`
`

`

`American BioScience, Inc.
`
`N21660
`
`• I IM..-,to4.1io
`
`... ~
`
`1<*1 ~~ for ~ct_ """*""'" Ia ...... nopaI!lcIo ...... _
`UM; (SIbnoII"_"'_d~'~~.'_~JoI"'~~.'
`"Y .... -..._~ CINM 36 _
`(nm) form 0/
`3&. _
`k:Iy the .. e Mill ,.1«.
`PIdiWIIl s..~. AbruIIIeIl ruppied • • ""'~eto)"llllo\o. II ..... ttoPIoJi1"lld powderi1tendedJor
`'WCoMlilullonllMl'l 0.0110 SodIuna.b1dt Ir+!d\OII.USP pIIorlO~ Infurrloro. s..o."""*,,,. Ead\1~
`~ 10 the PfOPCI'HCI
`......... eont.lift. 100 "'II o/~'nd IIII'fI'O*nqly 900"'11 0/ ....... " ....... in. s..~ .
`IabNng for the df\Ig
`lWDltUdln-. ....... <Odod 1'0 1015 poliontrr ~n_ ...... 1 mulmum ot_ """'_OI"""~
`nogm .... s .. arwc./S/udJo., 1huI~""'" 2 _ ___ _ _ ~ Inlha ..
`_II1II11 ••• 3C...r.rc. """"'" .. doul 01 ' 75 "9I'n' or 300 mgom' -... ~ p ..... edic8IIon or ~ G-
`CSf~ . s.. CIinIc.r Sl<i<Ha: 8teNlCotonoma;P1Iuo Z_w..tIMliar. _
`(MbpoclI_1or
`~ . .. ~)iI~odlort/ll~o/ "-'--~"'=-. s../tIdUIIon. f«_:atIcIllftSi
`0/ 2M~' admIroioteNod _It"..., 30
`cafICeI". - . . . . (~ocIb>:eI for injectobIo ,-"",I ... _
`ml'''''" ..... , _.~. _ .-Ioboell..w.. s..~ _ ... ~ Abfu ... 10 WAIl""'"
`~, ..... ~ poooodoo-for-.livtlonbMtn .... S .. ~ _AMWn!IWIM' ~ 1t:Jr~
`A<trIiIdI_. ROoCOftUiIlM - . ofol l>t Inje<2ing 20 m~ 01 n.W'II. Sod .... CI\IOIIIH "'Jt<tk>n. IISP. SH ~ _
`~. ~"" ___ ~. NOprenwodColiM is '*l"- priof tolll. odtIIrkt,.;.,nd
`
`~. S .. no-_~;~~A~~
`
`5. No R ...... nt ,""",1$
`f or this I*Iding NIlA. __ . 0< '~M. ~ ... .., _'Ill PI_ !hat .... 1M drug substMlCOo (lOCI'" ingl1>d~).
`cIRrQ prod"'" (foror>ut.tIon or ~ 0< m_(I) 01 ..... lor _1I'e ~t II -'<Ing .pprowl .nd __ pta '0
`- . , el ..... oI .... nj ~ _lei _
`.. "' .... _ r . jill ...... notbn,od ~ 1M -.oro/1M p.~"'_og.d In
`.... m."ufodu,.. I;H. or .... ofU. druV p,od,"",-
`I . De'c~rirtion c..\ln~ .. licil't
`. ,
`••• TIl. un"~IQn.d d..,r.r.. W I thh Is I n ' «lInl •• nd compie' ... ubml.ulon or ,..t.nt Inromtl/iOn fO¥ tho NDA,
`.-m,ndment, Of auppJomllIt ,"ndlng under .. clion ~ of till Ff{N~' Food, Dtvg-, .nrI Co.m.1k Act ThI. rnn..
`....... I!fVo ~,...,! Inform.-Iion I • .-ubmlfhdpunu.nI11121 CFR 3U.53. I .ct.., ~t'.m f.mIU.r."lth 2f CFR 314.53 '-rld
`/hI. subm/ulon compllH wid! tho roqu/"menb oIlhe f8gul.Von. I v.rlfy und" JHmIIlY of ",!jUIY IMt fh. Wt.fIOfflg
`I. true 'nd tOfNott
`W"mlng: A wilifu/ly.nd knowingly 1.lso .bt.m .... t I." ~ri",m.1 oH."so und" fI U.S.c. 1001.
`Ol~ S;gn.d
`
`.. , AIIIIIort:.d SI\JIIII .... 0/ NDA AppI
`
`or P_ Ownor (A.!n:mty. Aqont ~""_ Of
`_A.uthorindOl/iciM)
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`PatI"kk Soon-Shiong. Mr;;t'r~ DiQsc;.""". ln~.
`
`/3 MMlif'
`
`OYu
`
`NOTE: 0"",, .. NOA ~I"'n~tt~y ... ""'11 _
`d ....... aUon dl .. etty to 1M FDA. A po .. m ......... , MIG .. not 1M NDA ""ptlunU
`.... auth_ to ' IIIn tMoIKW1It n blltllll' not ,"I;ImH HdT-'Iy tofDA. Z' CFR 'lUl(~K') .nd {dl!').
`_
`Check app_" I>OK __ 1M Information ... ,_ .
`121 NDA~o"'r
`
`0 P."",Ownet
`
`AlI'M:fican BioScience. Ill(:.
`
`2730 Willhi~ Iloulcv.\rd. Su;lo /1 0
`
`,-
`""*.
`,,,.,,
`
`ZIP Cod.
`
`fAX N!>"IObe, / i f_)
`l10998USl
`
`0 tfDA AppIicanr_. I<It"..-q. AgD<oI (~.p", . .......... ) or oIhe-r
`""""'"'0<1 OIf"oew
`0 P.tent 0..-'. AIIotM)/. Ag~nt (1'1..,... . ..... _1 or o."e< " '_
`,.""
`
`CtylSt'!e
`San .... Monica, CA
`
`.~ N!>"IO ""
`310 III 1300
`
`E-Ma~AdcIfes.(if_)
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 1016, p.06 of 102
`
`25
`
`

`

`American BioScience, Inc.
`
`N21 660
`
`Tho """"" ~ 1nI_ br III" col .... ;.", .f m_ ... loom ..,.;.., ...... . --.' ,
`ialneIi<zI .. scottt..,. ~ _ .......... ..-. &lid ...... !U!ia ......... _
`IIoun ,.. __ .... ""' ............ rot ... ~
`.... ~ ..... _io'oriq .... ooUocbooo of Q:onnoI.,.. SUI<I
`. . . - ql1dio.. 1IIis ....... ~",...,."""" - ' oLlbis ooa.ru:. olio1'o<nloliN. 101<"","" ~ far .... oc:Uoc Ibliloorolao 10:
`1~ HId 0nIc MIIIioiscmioo
`COER (Kfll.OO'1)
`_fiill."t.nt
`1I00tvilic. MD lOin
`. .-1 .... ..- 11_ ""","" ,.spoNIoo. "cdl«.~ cf
`....,. _ __ ,.., _
`~"'uj<~. ",.......y...JitlOIl1J __ ""'.
`
`04" •
`
`FOAM FDA 3S4b. (7103)
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 1016, p.07 of 102
`
`26
`
`

`

`American BioScience, Inc.
`
`N21660
`
`INFORMA noN AND INSTRUCTIONS FOR FORM 3542a
`PATENT INFORMATION SUBMITTED WITH THE FILING
`OF AN NDA, AMENDMENT OR SUPPLEMENT
`
`G ..... ll.fo . . . tio.
`
`• T .. $\Ib;ni! polCl1! infMnllion 10 IlIo ~cy tho tIlProp<'iate
`pUenI dcc:1 ........ IOrm _ ~ .....t. T_ fOl'fM .... I vailable
`fDr pal<1lt ."bmiuloou_ 'The "",,",",al .lIN. of )Our Ne .... DnIs
`Appllalio~ will determine which form )<>u shoukl =.
`
`lS41a sbcniId be
`.... d whm
`submillUtJ; par:nl
`• form
`i:lfCrmAioD with ofiliinaJ NOA ...txniHi .... J, NOA omendmellts
`."d NOA IUpplc:ments prior 10 appoVll.
`
`lS 41 shaul<! be u.sed el\er NDA Or
`• Form
`IUPI'k",_,,,.1
`OI'P"","I. t1ili. rom. i. LO be .ubmined within ]0 "YO oJIcr
`"I'~"",a1 of an OI'Plicatiol\. tni, form should alJO be uocd LO
`submil parenl infOftlllUoR relaIin, 10 an approved suppleme~1
`under 21 erR JI 4.H{d) to m.r.,. the r"""",lotia", odd 0 no'"
`il>dic3rioro or oilier condition of - . ~ !~ JlmOph. or to
`make ."y othou ",,"Bted dlq_ "'Iordin, tho drul. dnt&
`prod\ICI. or IIlYmeIbodofllU.
`
`• form lS42 is abo 10 be used for palCnts w...d .fter ~
`"f'I"O"al. Puento IsNed after dNa IfIproval .... ,""UirocllO be
`submiucd within 30 dllP of pllCnl i$Uwlcc !Or the pllCol 10 be
`cormdcood "' imoly filed '
`fronro form 1S41 wi Il be uocd for 0ranBe
`• Only Infom\l1 i<II'
`BooI< Publiu1ion pu:po ....
`
`• Form • ....,.,1d b. submlned .. ""-ibedl in 21 CFR 114.-'11 . An
`oddlllDnal al!'l' of form 1142 10 II>e Orange Book Starr will
`upedik: pUeD! pulIliulioo in the 0,..",. Boo • . TIle Orange
`Bock swr addres. (lO of July ZOO)
`Is; Oratl£e Boo. Suff.
`Offi"" o f Generic DruB' OGDIIlrn~ 10, 1500 Standi"'- PI_
`Rt>ckYUIo, M D 201SS.
`
`• The roc:eipc date i. che du. choc ck pal"'c informuion i. oLoce
`S\amI>Cd in ct-.e «nlrll dO<;uOlCht room. PueBIS are consille~
`li_<m ll>edakm;eived.
`• Add ilional ""1';" of Ihese ro.ms moy be downlooded f,om the
`Inlemel 0" htlV-lIilmn. Pff 'YWIimoyItiIMJI""@aItt ... /or",'
`
`f1nt Stetlon
`
`Complete al l ilerm in lhi. sectiort.
`
`I. G~"e ... 1 s...cc;on
`
`1<) A:uwer Ibis question if ""plicable. If pi",," 0 ........ on<! NDA
`the: Un.ilcd SIoUJ. ~~ s;-e
`IfIplleanvboldle< re<ldo in
`
`''''<
`
`1. Dne Sulutlllce (Adive l~eredl.lIl)
`
`Com;>1ete . U items ;0 !his S«tion if the ptItlI! cll illlS the druI
`~ ilia " tho ....t>j«:t of clw; pendinl NOA. ~ 0<
`suppkll>cm .
`
`U J
`
`i'I""", che polym<><p/lio !'orm of III< dNI id/:ntified by the
`
`.. -H) A pII«It for . metabolik: o f Ihe Ipproved a<:ti"" i"gn:d.icnt
`
`",ay not be roIIminod. If tile paIcII' o1aims M "",pro>'Cd
`mdbod of usirll Il>/: ~"ed dru& product 10 odmiDisIe,
`the meulIolilt; the ~,...y be ,ubmiiled .. I method of
`u$O j)ll""l dc ... ndint on die raptlMtl 10 secIlod 4 .. f!his
`.~
`
`1.7) AIIJwcr III;. quest .... only if the polmt i •• prodc.ct-t>y_
`proeus pMeftl
`
`J. Drill!: Prodll.c (COtIIpo.iliotl!Formlll. cio,,)
`
`Comple!c all items in this seaiOIi if the J)ltlCl1t claimIr the d""
`prod ..... that is the SIIbJect of tin: pendlhl NDA. &ID~n~ or
`SV{I9lemcnl.
`
`loll An.." ..... 10 this q.oestion f. requit"ed only if !h< referenced
`pa\e1>1 il a rJOdiuOl-by"""",,'" patcnt
`
`4. Mdllod of Un
`
`CompkU oil ;I~"" in this oe.ctinn ifll>e p ... m elll ..... _d of
`.... of the ""'I pro<lIIc( IhI! is the subjtd of tho: padill, tWA.
`&mend"",nl or suppl<tn< nt.
`
`4,2)
`
`IdcrI~fy by number each claim fn the potenl thai ~Ia.itll$ the
`u.se:('l of the dIU, for ""'ldI !I;lpro .. ai
`is be ing sought
`IndiClle whcIhct o. not each i .. ,liYid,,", claim i, • cio ion fur
`• m<thotI(.) of ..... of II>< dntl (or ""'I<:h .pproval i. be""
`sought
`
`(1) Spe<:ify II>e pin of the proposed dru.g tabeHnl tIw i.
`cI~med by II>< potmL
`
`Complele , II item< in 'his oec1ion with rererene< '" the ~ ..
`itself.
`
`1<:)
`
`Includr I"'teIIt upl""",,,,, duo. indudlnl any i l.au:ll·Wntnall
`in<lud<: any
`pucnJ cncruion already In~I«l_ Do
`IlOl
`IpPliCIb~ pediatrit: exctusivity. The 1gency will
`iflth.:le
`pediOlrie exc:lu.l.ilies ",11= oppIic8b1e UlIOn publk,nion.
`
`S. No Rdtn llt Pal.lla
`
`Compkle this ""ction only if IfIplieabk..
`
`Comple ... 11 he .... in thi' section.
`
`Id) I~chld/: full addn:ss or puenl 0 ......... Ir pIIaIt OW1lU rtlid<'
`oulSidI' the u.s. inditll. Ihe <O<II!Iry in the zip code blod<.
`
`6.2) Autbwize<i lignat ..... 0Iedt one of lh_ IOu.- boMl tba' beSi
`describe< tile IUtltorized si~re.
`
`FORM FDA 3542. (7101)
`
`",,--, ... , .. ,- ..
`
`F'gllt
`
`27
`
`Apotex v. Abraxis - [PR20 IS-00 152, Ex. 101 6, p.OS of 102
`
`

`

`American BioScience , Inc.
`
`N21660
`
`Oe~rnent 01 Keal!h owl Humin Setvices
`Food and 0!u0;J ~nldralion
`PATENT INFORMATION SUBMITIED WITH THE
`FILING OF AN NDA, AMENDMENT, OR SUPPLEMENT
`For Each Paten' That Claims a Drug Substanc.
`(Actfv.'ngredlent). Drug Product (FormulaUon and
`Composition) and/or Method of Use
`
`F"""~: OMB No. C1110..0en
`ElI;>ItaIiotI Dale: C7l31.Q!
`SH OMS S-""hQIf 1
`NOA HUIIGER
`21-660
`«A.UE OF APPUCAHT I HOA HOI.llER
`A.merican aioS<:ieftu, Inc.
`
`Tk following Is ~"1dN In KeGlWnC. with SKUOn 50$(1:» .1Id (c) of 111. F .... ' Food, Drug, .nd COsnHllk Ac:t
`TRADE tw.E (OR PRO~.~:> lRAOE twoIE)
`Abnoxane'" (Nth Pldiwo:(1) fo. Injectable SUSIKnsiorl
`
`~c~ INGR.EDlEI<lT(S)
`Paclitaxel
`
`STll£NGTll(S)
`100 mt/vial
`
`OOSAGEfORM
`Sle.iic powder for inj«tJble .uspen.ion
`
`. equi.ed to be IVbrrlitrod 10 !he Food and Drug NlminifhllDn (FOA) wiIh In NDA. . ppliQlion.
`This pille'" ~rriDn Ionn Q
`amencsmen~ or ,upplemo~t " requ;red by 21 CFR 314.S3.1he _ I I provided in 21 CFR 114.S3ld)(4).
`WIttWI thilt\' (3O) d..,. I~ .. r .pproval 01 .., NOA or IUPPIemen!, 01 within IIIlrty (30) d.y. 01 " '_ at I . - polen!. I r>OW potent
`ded.ation ........ be submil;le<l pu,suonl 10 21 CFR 114.,53(c)(2)(i) wi'tI atl of Ihe ,.quire<! Inbmrion tIMed on Ihe .pproved NOA
`01 IUppiement T1loe i11ormrion submitted in tha dedll1llion form 5~ UJ)DIl or '~ef lljlI)foYlI wiD be the only InIoIlNItlon retied
`upon by FDA for ~ting I pate.rtl n!he Ora"!18 BoOIc
`
`For lund.-ltt.n or typlwrlta. nfllo ... (only) of th l. "port: If add~ional sp .. o;o Is r" quirad 10. Iny ~e __ • (1 .•. , on6
`that doe' not requi re I "Yes" ~ "No"lupon$ej. ple~ . attaCh In 8IIdltiQMI page rcltlvncirog d'IO quesllon numDer.
`
`FOA will not N.t p.unt Information" you fiJ. on lneompl.Nr pat.nl d .ct. .. tlon or 111. p.,.,,1 <Hc1.fltIan Indlcar.u ttla
`plt..,1 Is not .lIgl~ (or I~ting.
`For •• e" plfeflt submllf.d for III. /H,,/Hng HDA, ImMdI?Mnl, Of' .upplwn.nt ,.reBIIe~ .0.01''' I'0Il mu.I IUbmN .11 tIM
`'nform./Ion d •• eribed bllow. " you Ira not .ubmllting .ny plllnts f<>T III'. pending NDA. a/lflndment, or lU~nl,
`. .
`com f.r. .b<t~ • • 'etlon and u cfl<>n., and f.
`1. GE NERA L
`• . Un~ed ~ Polen! Numbe,
`6.506,405
`
`')
`~'.
`ilion ~ oj PI"" •
`212212013
`
`•
`
`tI . ...... o.t. cI Porn
`1/14nOO)
`Mel .... (al PelIIIl 0wr0eIJ
`2730 Wilshire aoul~Vl\Jd, Suite 110
`
`CitylSllle
`S..,ta Moo;'; .. CA
`
`v,~
`90403
`
`fA)( Num~("~
`3109911553
`
`T,~pllO .. N ..... k'
`J IO 81) 1300
`
`Iw>d_. (of-"'OI' ______ .. I.'.,
`
`E ...... t MdteSl (¥~)
`
`d . H..." 01 P.1en! Owoo.
`American BioSei.rI«, Inc.
`
`I. N!!I!!a('9'1l1 9' .,.....,..O:iyewllo _Ido. 0' moinl .....
`
`I place cI Mi'~ •• ..."h ...... U ... "" Siotc> .1<11,011 .. 410
`",..,"'" ""'ice oj p;o1ent ~rlirocal"", U_ Hodlon
`!>05(b)(3) and 0ll2)(B) ol!he FIIodmI Food. Drug. _
`Coo ..... ;. Ad •• d 21 CHI. 31 • . 52 Inc! 314.9(> r~ polan!
`_ , '" No.o. appk.ofll/t>olde, doo_ "'" retide '" h_ I
`pt.toO cl ~ ....... ilnln thl Un~er! Stat.s]
`~ WA
`
`CilVIStll.
`
`liP Code
`
`T@IepMno N_
`
`~ NO ... 0' .~""Iom~nI .. 10_ ...... "" ..... 1
`
`IUbmlt\ec! p ..... UII\' fOIlhe
`
`, II lIIe potent <ere",,,,,,,, ,_ • p:otlnt Inol "al _
`• 11Il10 "aIo'" ~ .t>o>e hao _n .""",111"" """.0,»1\' for IIob<l!l. io lilt ",p'olion
`
`<1010 I now o>pir;tlion<bl.1
`
`FORM FDA 1s.42. (7/03)
`
`J\1.. N "",I)ot, /il ..-.II,.,.)
`...... ~Iw>d_. ( '_1
`
`O'ft
`O'fl
`
`Ciil~
`
`O~
`
`P'lIe 1
`"" ........ ,.,,"'_ u
`
`16
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 101 6, p.09 of 102
`
`

`

`American BioScience, Inc.
`
`N2166Q
`
`..
`
`., -
`
`" - , . ,
`
`' . l
`
`.c •
`
`1InI:dMId ... !M ~~ HDA. __ . or ...".,_011
`
`U
`
`u
`
`"
`
`FM Ch. p.t-nl ,.r.r.llnd .110 ..... provkH ~ followftll Infonul1on on III. drill wbsttnc .. drill ~C1 ... 1i'0I' ,"«hod 01
`.. . ' ..
`II •• lIl.tI, CM ,ubJ.ct 0' ttJt IHlId/ng HOlt. .mMdmMI. CH" '~pIem."t
`..
`" C'.; >:' .
`.-
`; C
`2 .. ~' $~lIi,~, (~:~·~~tt
`" 0.- tIM petei'll ~ the dNi ~"'III it I"" .aw. """'~nI ill llIe ~ produd
`0,"
`o-_polenlcl""",.~a~oubot""lI"IaIit. ~ paI)omOfl'tlOlll\e..::liw
`0,"
`~Ion! <leOCtlbod In ~P"Cf"9 HIlA. ..-m ..... or . LIjIpIomer\t1
`the _!('q_tIaI U ll "'(",; <IoY"" certfy"' ... "01II1II dr:e .... 11* decIII'lIIon. you h .... l1l1~
`<lemo,,"Ir.llnIIlhfl • dnrv prWo.rd <JOIIlalning 1M ~ ... "JIPI wi! I*\OmI tIM . ....... ~ dr\Io product
`0,_
`<IeI.cIbod .. \he HOA1 "" type of"'! dati required .. <Ieo/;rib6d ~ 21 Cffi l l~ .S3(I:I).
`b)' tIM polen, to< ""k/I yo.. ....... tho ~.tl """~. dtocrt.cl .. U .
`1.4 Specify tIM ~ !orm(a) _
`
`I!l~
`
`I!l~
`
`O~
`
`'-' Pot, ..... paten, dolm ~nry ...... !.boI~ .. of (he a.:tIve "'11_ '" _"g ;"tIIe HOI\.. '" 1~1
`
`(Complel. !hi W_lon In Hdioft • l>t __ 'Ille Pile .. clloi"nt • PGndng mdbod of"'lnrI ~hI """"i"Jsj
`drug prtICI"ud 10 1Idrn1"" le,"" ~H.)
`u Doe,,,.. Pt!enl doi"n "'OIy all nermediale?
`
`Z.1 "I"" paltfI! _~ In .Z.l Is • l\iodud-by·p,o"en ~"'l i. tile fIIOCiuo;l dolrnea i/o In.
`~ Il0\1l11 (AIl.nt_ 1t requ"""..,1\1 f tt.. ~.nl il a pr«Iuct-OY~1S p.ae .... ,
`3, D~ . ..r.:icrllel (Co~~MIo~olJJ'iI(.tlMI
`~.1 ~1Ie~Mdo 'lIe d~~CI," de • 1 Cf~ Jl • . ~, irllN! per>Cllng-.
`
`_ en ! , 0< IWP9 ..... er>l1
`3.2 ...,...lIIIplI_ o:I .... ..,'Y.n_IaI.1
`
`u
`
`I ~"" p .... 111 rer __ irI U ;" produCl.--by--pr«M' PO""". I, the pn>d1lCl eI._1n the
`~enI - ' " I ...... "n,_, if. ' ..... ire<I on", Iftl>e ~"II. "ptajllCl"'H>""",1I paI_ )
`
`... ·M.lhodoIU ..
`
`Spotl~ mu~1 ~ubnoll III. ,"~OII III "_"" , .'P.,..~ frv ... " ,.._, c_ dasmIJIlI • " ' ._ rYf II.tng 1111 ,..,.dInfI dtvp
`prorhtctlor _ _ ... ..aI/. ~ SClIIQ/IL Fot_ .. , _olin_claim ~,P_III.k>Ma,""" ... _ .IIoft,
`... 00401''''' _ , d .... on, Of "'",. ..... n_ of uoe ,... """'::to 1111'_11 it booing OOUQN '"
`I8l Y~I
`VItI pending NDA, .... ~ ...... Of .u~?
`1)·22,24_14,36-40, 44,46, 48 , n, H, ~6, I OfUM ,... ..... ic;II ~",.., is be~ OW\jII,ItI'bepending NOA,
`U Plten! CIfIim N\lnber r., li&ted ill !he pelenlJ
`Does ,,,- palen, elfim NIe,.n=I il 4.2 ~ • ~ method
`ame._nt. ... ,,,,,,,,_ern?
`Ci!:I y ..
`$8,60
`
`0'-
`0,_
`
`0 ,"
`
`""-
`
`0,"
`0,"
`
`I!l~
`
`I!l~
`
`O~
`
`O~
`I!l ...
`
`0"
`
`0"
`
`0,_
`
`FORM FDA 3542.1. 11/03)
`
`P'IIe2
`"" _ .... o ~ , ... , ...
`..
`
`17
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 1016, p. 1 0 of 102
`
`

`

`American BioScience, Inc.
`
`N21660
`
`• • 201. lilli' __ 10 4.2 ;.
`-t .... icIoordywllh t~
`kIIy h use oo4I;tI .. t..
`...,.101M_od
`1I!>dng lor 1M d"-'i
`
`... '"
`
`u..: cs.-~orm.lltod _~.. ~it~~~.,
`
`aM1>t 1,),22. 2~. ':H<I. 30. 31-40. ~ • ..s. ~8. 504. """ 66 • Abraxane (...0 """0.1) lor ~bIot _Ion b •
`n....-_~_C...c)"'"" d~. s..o.~. Etcl\N>i_HvIof_ IOO"'ild
`... tIoIy lIOO"'I1 01_ .1bI.n11n. s..~_ ThIolormulolJon .he __ Is. s..
`padtadj • ..., _
`.... aII
`o.~. ~{_PKI/tUIijfof~ I _Ion;'_""IMIl_d
`<;111\06(. SHIIIdicIIicn. ~(IM$fICI~C~.a.IfI.,.IIt.ull~J\UO;IIorIaIOA b _
`_
`(H$R:r). Fo<m_ll\ic:_"'_.~ ........ (_
`...... SN.4dWtH RHcIic:wtI"I)". ...... /1) _
`
`~ilaxdf ... ~ Iutjlt/llion) ~._ !JI2!IOmg/m' adrn~ ~""_3O "'''\MI_''Il_
`
`h .. _n ' -10 M olJoclNt. SH " " -MId~. No jQfMdicaIkIn 10 NqOkecI ~""'IO \hoo
`1dm00000000n dAt><uo .... s..ao.s.g._~ ~_'--fic:wI PtI<:auIiotI •.
`
`ell .... 21-29 • N l_ (notb paella.!) lor Irjed_ t~ II • llloopaltido llbumln--llouftCI (n"') ...... !JI
`
`ptdiIaDI. S .. ~ ElC/llmg ....... oIIl,..,....,. l00~oIp..:1ta>:e1..-.;f 'I'Pn;ndmllllly 900"'11 ofhum",
`t"'""'"' s..--. Abt-..d .... not
`.!t>umlft. s...~. This /ofmul-",".1rH '"""~. s..~. ~ (nab ptd_1or
`~1t~)IIIndC.od 'ortnl_of _
`_
`"""'lin C~ophor..eL. _.IorIIlypeI'H~1Ivty .. tdionI toNlI'aQ", ...,. lite. s.. ~~.
`~ ~ (HS~. HII\.WII8IIIa.!fIt most mfI(IIWlt ".",,,,,Iogir:: tDllicity. __ dol. dependent .1Id
`..... 1_"'II1,.gid1y '--1I1b1o. s.. .. _~, ~ Go.- a ( .. SOO--.....'J_-"'"
`OOC»/IecI in 12'% !JI p.tianIo lnoI:1ed ,.;tIo NIt ........ s.. A<NwM ~: '*""'
`Among patitnll C ... ted ..
`l mew.tatlo boonl canc:e,~, ... ~ COUIIII ~ _
`!fit ""_
`500.,...,.".,,' CO .... a) .. K of tile
`0/ 26O~' odmlnlsllrod _"""I/y _lO minute, .... ..., 3 _.b
`~1enlJ t_ ...... _
`01260 mg/m' 0IlmI*0d to U% In pallentt NCeMng Cr.mop/>or-tlilod 1>Idit_ ~iOtI
`oII75mg/m'. SH~ ~_ft>bQ/C. F ....... &llItlebnWlt CI"'*.AInxan. (neb
`oj. _
`1'.0:1 ...... 1 to< ~ ... ~J II. _
`""_ I~lObe~_ . S..~_A __ .
`
`CIaftIt 30-32 • Nlru.ane ~ ptctto...., b" iniKtabito IUSpentjon 10 ..... 0~1\idt ~""" (Mb) ' ''"'' of
`Pi~. SM o.~. ~ ling ....... vial ",,"'IN 100 rng 01 pacru..t and lPPfO_oIy 800 mg 01 h ..... '"
`.......... s..~ no .. lormIllIU"" is free ffI;ro .-n!J. SHDe~. ,.".... _(Mb ~ ...... ) for
`1nj"'_ IOSpe~lion II o.:ti<;I1od lot II'Ie ..... """IIt...
`a OM l_. SH l_fICn. In general, 'l'1li
`...-,. 01 """ofosIIc mOl'ilolol.t.iono ...... doM--<Iepoord".u in I'll*"" ...,..;.tng t",g~ AD, ........
`Ir.qutney _
`SH~ RoM;tJonI, N.IIIOIog/I;, p~"", ....... ~wa, CIIIHoYecI .. i54% of III 1'."'" (10'% III ... ,,). SH
`..... ,Iy mproved Of '""'* with .... Z2
`AdYetW R,.aiona: ~~_ ".,...,.,....,ropolhy _. \I0Il cawo of Abft.wI,,.. d~ in Il136e (."') d
`III plllo"' . .so. ~ ~: N-..ro;c. SiAllit)' I)'I!'Iplcms _
`g'_ ~ P<I~raI "'U'OIIatlllol __ ..".ned In till clinl<:oI 1ri.l See ,01_ RNcIiMI: Ne~ Other !hln
`dayo 01 ... """,ing NIt ...... _opy. $H A<IWtY - . : ~ p,..riIIJng IIIUfOI>II/Ilot ,nulling """'
`proOf tMlJPicl ... nI7t I _~1nd\I;ItIon I9r ~ .... thonPJ. $H ~ ~: Noo~ No In_norl 01
`i." .... nou"" ""'" 30 m_. every ] _ . hll _n._ to be ."._
`
`"""raIogic """""'" 1-.0 AI>t_rw odtII"'Irt,11icft haw bHn .... « 1 .... ) _ h_
`pe~'" _ t / l y . . . _
`in_ .a>oomir:: lInII<I. m,,,,bOle ~aIopat!Iy. COIIfuoIooo. dltziMts/lighltwl _ _ •• 11"<1 m-OOd
`I~"'tioo 'drop •• , .... _ s.. A~ f«looclioots:Neutrllo(pc. NI.--ne does not con\Iin c.-I>ot-l':L. t ...... lo"
`I>ypoo ...... ~IMIy .. :lOIiOtIs 10Al>t.,.. ..... ro .. ro. s.....- ~~~_s(HSR$J. For
`"' ... tltic t.<e.ot canCl<. Ab.-.... n. (nab p,cIiIau~ for injeWIble I ............. oil • dolO of 2eO mgfm' _ t_d
`. S .. 00 __ vtd AdtI>ir!Wnolion
`
`CIt", sa • Ab" ", ... tIIIb Pld~ .. eI)Ior~ablo IUSPMIIolt iI. OIInapartde Iblm~1Id {ll8bjlorm ot padit:w!l
`SH o.~. EldllingIe-usa .... 0!ItIIain1 tOO "'" d pacIiII:q1 and lllpmUnalt/y 900 mg 0/........, .ltIunin.
`s.. o.~. This lormull1lo<t " !ret trgm _
`. s.. o.~. Ab.-I ..... ( ..... paoliWal] rorln;ocUblt
`!
`IMI-.. SH_. At>ro.<o ... _I'101"""' ....
`lu. peno;or.lolnckl1odlOftll<t_
`' ''' __ 1'0''. s..-.. RHctiot>o:~
`c.-.... ophor-E l, tllerolo""VPO ..... ~ .. _
`_
`~ (HSR4. FOf ",_t.tic ..... 01 Clro::et. AllrUli'lt (~01 !Of ~bIo . ... poonolon) -' • dIH, 0/ 2&0
`mp' Hminllt __ .-I/y __ 3O ... inu\et ...y 3 _ . """ boon ._ 10 boo .tIa<:tNo_ See Dca __
`ArtnftrtWioo' .. No prlltl>8dicltion II ,aqu"'~ ~rior 10 Iho _lobI/itkin ot At><uo.... s..!:Ioug. IlId ~
`~tion_~ Ptocau!DIs. ~ tt'Ia _N:te """"m d"""","ltotedAb.-l"", imc." ""'1'tI' .
`""""""nIion. Tho .... 01 opeda_ OEHP ___ oontoInoI'I ... O<Im .... _
`• _ . poIyWIyt (;hIOfkte (PVC) typt IV ' Ig, SH 00, __ ~: I'I'wJ*'lIion 1or1 .... -.aw
`HI. iI not _Oil)' 10
`. ... <If tdmini.'e, A - . . inllulonl. S .. Douge trId .. ~_ : Pro.o-m;on A:Ir ~U$
`A _ _
`_
`
`FORM FOA 35421 {7/O3)
`
`Apotex v. Abraxis - [PR20 18-00 152, Ex. 101 6, p.11 of 102
`
`18
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`

`

`American BioScience. Inc.
`
`N21660
`
`4.l.I .11-. _, 10 4.2
`lIM: tslAlmlflrldicalbl .... 1IIOIIMd of,," ~ u I<If<III'itd ~., ",. ~ ~J
`OYIH." kIentII\f ...,.. opod-
`CIaOII GO • ~ (nail pacltuoQ lor ~ • ..".,....... 11 • __ ....... In_ (/lAb) Idotm 01 , - . " ".
`/icily ItMI ..... wI~ . - . s..0e~ EKII . . . . . . .taICOOUInIl00111Q oIp~...., 'I'I"Oo:mtWy900meofh....an.Ibl.mIn .
`SH 0. .......... n.1I1oIm1U1bo 11 11M /r()m.-. SH~. ~ ("." padituIo1) lor Ir1«ftblo
`... De 10 1M prOPOMd
`01
`w. ,,_. s..~. Abn.xar-. ....... not contaln
`\alle-llnglortMdNg
`C .... """"'"-EL._"--'.-ynoadon.Io ___ "' .... SH ___ '~
`Ructi;w (HSRsJ. For IMIUIIIic _1 _ . ~ (rIIO p..:IitueI foI ~ .~) ... dow of 260
`m~· ___ _ _ .1y ....... 30min_ .... ,.,'_,... __ lOtIIO_. SHDougeoWld
`~. Hojlt8tltld~lI~ prlotlOtn.IOdrrWni~r:>fAtl..,.._ s..OGsIgooWld~;;'J:
`~ 1It!dMnh'#aIior>~.
`
`._.ion ;. IndiooIIod 10< !he _
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`:'~ t: (~ !t i:i, ~ 1 l"<~ ~ .:~ .
`", ..
`" j . .\ ~ '\'!o~ ~~.~. ~-' .'
`., " , " .' .
`5. No '!.tmn(htlt~
`For lhit pendng N~ _dmen\. or ,~Mt. \lIeN Ire no NIIvanI p_ II1II claim 1M dNg I!bIl_ (8CIIw Ingredlenl).
`CInJg I'fI)CI<Ir:t (formulation or~) Of 0Mth0cI(.) 01 11M, Iorwllleh IhI 'Ilplbnt 10 Mtlirq 1IlI'PfOY'I ..... __ pea to
`_
`. ...... "'pOle'" t~ CO"'" ~""' _1M N. ~ _btIM<IbyltMo_oIt1o. ~ otIQaged In
`!lie m..,ufaclLtfe. Ide. or.1Ie oflM dRIll product.
`
`.
`
`'. '
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`O'u
`
`6. Dec:1." tloft C.r1Jt"",Ii ...
`
`..
`•.. Th. undwslgn.rl dKtll'I5 _I W. b .11 .ccu,." and compt.r. . uDmI .. la" o( JMr."llrrfvrm.Uon (or ",. NOA..
`
`• mendm"'~ 0' .upplto",."tp.mlirrg umhr .. cliOJl 505 offtl. F.rh..J Food. Droll'. ,nrl Co, ..... !k A ct ThI. fI'tn..
`senstrN.p,t.", 1~1Io11 b .ubmm.dpu~u.,.t to 11 CFR J1".53. 1.