throbber
EDIT ION
`
`2000
`
`U.C. DAVIS
`
`OEC 2 3 1999
`SER. REC. LIBRARY
`
`PHYSCANS'
`DESK
`REFERENCE®
`
`Senior Vice Presldent, Directory Service.: Paul Walsh
`
`D118Ctolof Produd M""allment: Mat'll A. f riedman
`AuoeJale Product Manager: 9iM 51l111Jihnessy
`Senior Bu, lrlH' M..,,,er: Mark S . R'tellirl
`f1n~JIII An al)'$l: Wayne M. SOltIs
`Dllmo. of Sale.: Oiklan N. Bal'$8mlan
`National Sat •• Manage •• Pha,maceutlcltl $al., : Anthony $ofce
`Notional Account Mon"ger: Doo Bruccoler1
`Senlol Account Manager: Fronk ~rkowsky
`Account Manag ... :
`M8!Ion Gray. RPh
`lawrence C. KealY
`Jelffl'f F. Pfohl
`Suzanne E. Yarrow, RN
`ElKlronk: Sal" Account M_ •• ,: Step/'lerl M. Sdvefbeli
`National 5 .... M3/\3Ier, Medical Ec~. T..s. SlIM' EWI Gaffney
`DIr.cIOI o. 01'OCI Marketln,: Micllael Betw'lett
`Ul t and P,oductlon Manager: LOI'T&loe M. Loet11r.s
`SeniOi' MarkeUng Analyst: Dina A. MIIC<Icr
`
`Dlreclol, H ..... Bu.I,,"1 Development a!Id
`Profn,lonal Support Service.: Mukesh Meh~. RPh
`Manager, OrYe Information Se",lc •• : Thomas Fleming. RPh
`ONi Information 5peclaUs t: Maria Deutsch, MS. RPh, COE
`Editor, Dlrtlctory Services: 03Yid W. Sitton
`Senior AUo<:late Edllor: Loo MUrT8'1
`Dlreetor 01 P,oduetiOfl: Carrie Williams
`Mllnll,er of P,odL>Cllon: KJmbefIy H. Vivas
`Senior Production Coordinator: Nny e. Brooks
`Production Coordlnalors: Glaone Car:tldonna, MaO!! Volpatl
`Dl la M.nater: JeHrey D. Schaefer
`S,nIor Fonn.t Editor: Gregory J. Westley
`Indu Edlto .. : Johama M. MIIaor. Robert N. W08mef
`Art ... oc:tat.: Jo8rl K. Al<erhnd
`Senlo, Dlli\allmqJn, Coordtn"Of: ShaWn W. cahill
`DlIO\81 tma(lng COOI'dlnalO' : Frank J. McElroy. lit
`EI,ct ront" Publl.III"C Dnllner: Uvio Udlllll
`Fulfill_nl MRn .. g .. " !';'''phAnifl 04!Nsmll
`
`0III0atI 01-" ~ c~ FNrib!nI_ao.r~ 0I'!'i0er:c:uru.B. ~ __ • _~-,. l. Sw_ geOIl; """ ~~_
`~. ' - M. _ ; lob ~1JcIenI _ a.t ~~. s_ M . ~; 0tIe( FIMt!t:iI!t 0IIkrer; ~ CMcII: """ ~ _ ~ IIMIy
`01.,. __ . _Busnesl~I.JncIIIG. ~, 1ob1'fttfkJt1rl. "'--~06WI A.. PiUer; I'icePlesidonl. fNnOf: Domo Sln!a!p&.; _VicG 1'fnJdont.
`1»wcIor~ ; P-.i w_, S«!Iot _ Pre~, ~. _
`VIce ~ Inr_ Sltarctits: R.....- lCMller
`® ~ on ftqICIeG P@III)ef
`
`R. 1'II<e; _
`
`Apotex v. Abrax is - [PR20 18-00 151 , Ex. 1008, p.O 1 of 9
`
`

`

`PRODUCT IDENTIFICATION GUtDEl309
`CARNRICK
`........
`.... , .
`
`... u ....... ___ l
`I~po--",,~~,-
`~j~4 ... L·"W
`
`• Hol. mln.(cid:173)
`
`I *""'i_~~-'~
`....
`• .... <C.
`.. ... "'
`
`, .... I< .
`
`.. .. , ........... " ........ , ,-...
`
`.. " ..... " .. _ .. _ , .....
`. ........ " ..... , .......... ~." .. -, .. -... _ ... _ .. , .. ...
`Il) n
`
`M • . - .·
`....... ...". __ 1MJIeU. USI'L
`
`V.P .. IIP
`-------.l0l0p0ll001. COCIM'"
`
`, ... , .... " ........ -.... , ~."
`
`M . ..... •
`~~~~--
`
`~~
`/100 -=~)''::I:: 20 ..
`("'~ fO< '"10< ..... USPI
`'''01''_'''''' .............. , .. ..
`
`.Ii'!'
`
`Ii' ~
`'" ." ..
`" ..
`~
`." ..
`
`-.~
`
`ZERIT'
`
`....::. == ..
`
`',;f.;'
`100..,
`50..,
`:lERIP
`PI.Unol" AQ
`,·'-"'lklrOr .. _ ...
`J<4IMItiIO~""l
`• ........ , ......... .. c .... ' • III BIG PHARMAC£UIICALS
`
`., ........ "",'"'. . ....
`
`.. ~
`
`'i!!
`
`.~~ m"
`
`W
`;1:1
`
`~~
`
`w
`
`.... ' .... , ...... , .. _, .....
`
`~~
`""0,,1.>-
`_ .. _USP~
`
`.• ~
`
`-~
`IQ "'1'1101'
`_Ikw~
`0, _' ... " .. _
`.... " .. ' .....
`
`..
`
`••
`
`a_tril" PDM
`J_~",!"", .... u .... ~, USPI
`
`....
`
`PII"IIIH .. '
`~.lISI',",~.USPl
`~"11325"'_
`
`........
`
`" ..
`. .....
`. ...
`~""""t.tr"'l -
`." ..
`
`80nhll' Slow·A,I . . M
`
`• .. , OI'
`
`"~.
`
`.... ~
`
`.~
`
`..
`
`P'Opa"'~
`~~ti'Ii .. ~
`
`.. ...
`
`C.pltl •• ..,d Cod.lne
`0.1' 1",p, .. l lon
`I ... ~._"'~l
`'.M'
`
`~_""'l..2nJ{5mL
`00 ... " .
`
`.
`
`8657
`
`.. .,Iu "
`~~-.~
`
`........
`
`..-
`
`,.
`
`•••• ,,«
`
`.*
`
`'.
`
`"
`
`:.- -
`
`, . ~
`
`-~
`~:'=:~.,.
`TAXOL·
`I-r~
`
`. .......... ' .... ""' ......... ' .. OM
`
`~ .
`~ 'I
`
`=';';""1
`
`~~~
`
`M •• u.' o.e. '''~fI.IOfI
`-L~UOl~
`
`.~~
`.0,1 ......... 10150 .... (100 .... 1.
`VIP •• ,d"
`• d)"""""' ....
`
`I
`
`II ~ <
`I· ~ , ~~
`
`Mototln"
`(_ .. \110 1It .... _
`I Of I o,~ OJ
`
`........
`
`... ~OIO)
`
`400 ...
`..
`Skl'ul",
`........
`I"' __ --'!~~"". ~·'Cn"'!C
`
`Onnd,.'"
`'''''_ '_' .. Ui!!L
`
`l~:=e
`0.1,1 ... ••
`
`· .. -··· .. ·~ .. I Po . "
`• i
`• •
`~ :.."":t' --.....
`m_
`~~ ........
`• ~
`~_t .. _ ... "" t~ ." ~~
`
`315"'11
`
`,,'
`
`~~
`
`.up,I'an·
`1_° .... _ __ , ..... OJ
`
`..... ""
`r
`
`.~
`
`Nol .hl.~
`l_iI>I;l .... ''''' .... ' ... 1
`
`m~
`~ I "" __ -'I
`Til_X'
`CELGENE
`
`'.*
`
`'"
`
`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1008, p.02 of 9
`
`

`

`PROOUCT INFORMATION
`
`~ - ' 0I0p0MI: sw...-;.". -'at.! wiUI
`-....m."-... ~SkioI~......-I ...
`~-.lIIIt_~with_uod ......
`_.ladlrllM_ ... --.-...bonl .... lloalOd>.
`
`""r-._Id bo _ ~"I:Y. '""" .... of 1"IJIeo,
`
`• - .--
`...,"'" - ... - '"""'"
`- - •
`~ ... , ,~
`...
`,.
`-"'"
`- U .,
`'-
`...,
`,.,
`....
`".
`""
`z,
`'''''
`
`T_"-.....,.01_
`
`BRISTOL MYERS SQUIBB ONC./lMMJ881
`
`'M
`
`,.
`'"
`'"
`
`•
`•
`•
`•
`
`,
`•
`,
`•
`
`,~
`&
`
`."',,"
`'"
`21.1
`""
`,.,
`n.'
`
`J Id'IItia&_
`p,....1lDII~_io
`_ __ ad~fIlthodnc.
`r.-I"'_ .... _~_.--.of_
`dnIp oIIoou.ld be ........... s...nJ pidoJu... .. \hit ....
`pubtiobad. ... "".". io .... ~-'
`joclhnot _
`Ibol 011 of tho """'*'- _...w ill tho ~
`""-'"1" """""'""lot.
`
`politic ....... 'IlIo_. 17 .. ....aw.:rt ...-. ...u..;.
`
`HOW IIUPJ'l.IEI)
`llUBn.j~ ~ _~ tlSJ'l1l
`~ ...........,j III tho .... wbllt~ .... primoril;Jo
`D E8CIUPTlON
`...... 1aIIIoo .. IOIIo>on:
`TAXOLe{~oI) \.ojoccioD 10 • -.. __ ... oIla:htl!
`6o.,,~tuoI. _lad roo- tho boloao:e. I~ "'~
`JtmdiM with bu ...... I"' .. . . . - &ad tioou.o olao
`601IIJ-EM:b~>iaI~60 . . fIl~
`,.J1owm-.ooII<Iioa.11 ioOl<JlPlioclM' ~ ......
`~ tho, pod!t.u:oI .... --'>ahsod prim&rIIy ... 60·
`<III HCl. tJSl> ... NriIo rad_ ~
`lnlODClod "" di"',",- wiUI • ...n.IoIoo ,....,torol lUI
`_
`powdor, HOe OOI~'l2.IWaIlabIot .. _ bocli(cid:173)
`tho .,..,.ru- P450 ~
`pirr ... iDtno_ botv.lool. TAXOL 10 ....w.w. bo :10 ..,
`~tuIll to,.
`(6 mL~ 100 .... (l8.7 oaL). oM :100 ... {M ...w .. ~
`CYl':IC8:...t .. _ .... ~!'~
`oiduall;r . . - rioL
`¥\ala. Itod! ad. ofMailo _-"= ooIulloa ___ •
`1u=1 w_ ....
`c.u.I aad6o., !'~. bJc:YJ>3M./~_.
`IOO ..... -EodI~""*I_~IOO . . "' ........
`bic:iD aCL tJSI' ... -ue rad_ ~
`tho -.boIiom ol~ 10 6o-h:Jd! 0iJ
`.,.podiweI. m .... ofpoorilled ~ £L' (poty.
`powdor. HOe OOI&03M3-:I2. .... .nobIoo .. _ Uodi(cid:173)
`bibi\od by ........ of _
`...... ,..,.IL
`.. (loa
`0 1
`~_oIIl"""tt.~( ..... )~ledolcohol.
`"'" Pocli""-"'tJ io .... 1...-..1 product with ",,111_ octiTU,.
`Jluo_ ~ ..... , .. b
`<J<looporiI!, Iaip>-
`oid...u,-~..w.
`St_ SI-.", powdor ....... tnIIleoI_ ttmpOn'''''
`IIdoo, HI!pO!Ildo. oM YidomotlM). but tIt.t ......... tno~
`w-4O'CC6t' ..... n
`...,J ...-.iod ~ b<Dd ....... Wl<rwiDa: --.I _
`TAXOL 10 tbIalMoIoio • .....",\hooIk __ n..."
`""'-"0. no. theIII/ooIl _
`'""" _",lad ........ 10 -.bit roo- 1 da,n ., __ "III'
`lOr podiI.o>ooI io 6Il.20-Epoo;)-.
`pom ....... 16da,n ................. :r~(sr-4l"1').
`1 ,20.t,7~.Iu"Ia...""~.II_._ 4,1~
`___ ... ~lIotaiIoill_1IDIll
`.... :&---. .. \s.- onIh 1:ut.$SM'· __ I""~
`--..
`Poc/Ic.u.l1ioo tho """"""" ............. Iono...,
`
`odcI, ...... ~ •• poo:iIo iohlbi1<!r ofCYP2C8. ..... boo
`bibited tho bmatlooo ol .... ~tuoI ........... '"""
`HnMi= 01 pOdil.01Ol ...., ..... be ohond bo .....
`pIwu
`. . 0 . . . . It oL ~ with _~ \hot .... JI>l>.
`....-, ~ ... 1obibI ..... of CY"P'X:II ""'""" CYl'SM
`cs.. PRECAI1I10Nll< Orvg Int.ncIIono 0Ktj0aj Tho of·
`r.c. 0I...w .. """,,II< ~ "" tho diq!ooition of]l!!·
`di-.J boo .... beta ......... tod.
`'-ildo iDlon<tloao 01 podil.Uotl with .....-iIaAu,. ad·
`1Ilio1a ...... _110M ...... _
`10M_ I'onull)' III";·
`
`_oL .....
`
`"""""'"
`L Rudolph R. w.. DL: ltioIocJ _ n-oo_l of 0..-
`1. R _d t;ou lOr 11M Sofo HuoIlinJ of I'amIr.tnI
`~ ....... 'Enn_ I.,jmioo:A_.J
`C'" 000<0I1987; Ullt-UJ&.
`
`-~£L 10 tho ......... ....-..n: ofllASP AIr·
`-CLINICAl. 8TlIOlt:8
`1'Idi1.01Ol1t. -.I ... tunl<rot . . . _I tho. ~
`io.itlol ..."w oIotliDo _II diotn1Ntloa ... Il1o periph,
`.......
`
`.. ,; "" od ~ t-fIH PIIbIic:a_ No. ~L For
`oolo by tho Supori,oleridoo.. of OoeuuIoIlllt. US Gov.a.
`..... , Pn..w.,: om... wooI\iocIon. DC - . .
`L -UlACaw>o:iI ....... GWcLoIi- r ... ~ Pa.w.tonol
`AIl'Ie..,' od
`.J).JlA l1li&; 2U {1l)o1 __ 1692.
`t . t-fotioDal Stud,r Commiooioa .. C~ Es.,.....(cid:173)
`"-'-'>J&tiooo .... IiaDdIiJ>c c,.....,.;. .......... Ani\-
`0l>Io er- Loooio P. JoS-ny, 9c:D, C\W,....", N.tIoo.ol
`Stud;r Cammiuioo> _ C)'Io&osi<; Es_ ... M .... eI ... •
`~-~ _
`1'Idi1.Uel1o. whilo!. ... ·wbl .. <I)'Molliae __ onIh tho
`Tho ~ uod 0l1ooo7 oITAXOL(podi(cid:173)
`
`178 ~ _ .... 800cca w-:h_ 02116,
`.... poncoIliniuJa CnH.,NOu aod • IIIIIlIctIlu ~ '"
`I&Ql) I'I,ioRioa (130"... __ 2A boant) III mmbiDaIiaa
`~. CIiDlctJ o..o.IocIad Society ol Auotnlia. ~ ...t
`863.1. It io bicN11ipophili<. feoohabIt Ie __ • aod .-Ita ..
`willi ciopIoll!l{76 .... .., iIo poa.iomo willi """-'ad ........
`R.
`tJoo,o .... $afo ~ oL AIllmO!Dplaotic
`........... 2HUI7'C.
`..-r ....t no prior ~1'1 ......... ol ... -..I la •
`....... ~M~J~I~;~~
`, .!>Itlcoa1U ....... 1M4, _1tOIIOd I .... .,....",.
`_
`CLINlCAI. PHAIlMACOLO(;Y
`•. J_ RD •• 1 01: 8ofo aODdlla,r of ClMlIIOIIIonpo~""
`pbo4>Ido 160 ....... ~/o;.pIotla 76 ........ '1 duoiool IrioI _ .
`....... .." " Roport _
`d!>dad by Il1o ~ o-Iov Grooqt(GOO~ A .... 01
`CA-A Ce-r J"",..s f<w C/Worialu llIU; {SoptlOctl
`410 ....... onIh s.a.,. III ... IV ..... (>.1 _
`I'OOio:Ial
`"'-",.
`m--.rwr.~ II!jIOJ"!!COor!;r" oIuunt - : l
`'.~-"ofl~~~Ao-
`...... ~Po_lIttu" wlthTAXOL iIo.".,biaa(cid:173)
`___ B..tloth! OIl IIoooJli:Ir C)'IOIOdc oM f/.ounIoo;ot
`tIOII willlciopiotill bod~ IOIItor 11_ .. __
`Drup."", J H.., n..r... 1\190; 47:1033--1(H9.
`(modiar, 11.8 .... 1110 _tho, poO.OOO8) uod -rIJ 0
`_
`8. ~0=p01iOllol ~ 10 fIuo ..... Dnop.
`(poO,OOOlJ) ..... potN willi
`"JOOr ........ ....tWo...,..,;..oJ _
`(OSHA WORK·PRACTICE CUIOtulf£S)."'" J HtehJ,.
`-.....:laId thttaP7.
`s,... PIwua 1~1""'1M6.
`\800 .... ' ...... 01-'_1
`Tho __ _ , praIIo lOr pdIoDlo .-..... TAXOL iIo
`OIIIIIhiDWoa willi aopIoliD '" Ihio ....,. ... ...,enfIJ ""'"
`.... tho p!MIiad .....,.. 01 010 .. " -
`- . will! !hot _
`812 1'"_" ttuWd with ~ TAXOL iII10dWeol
`on! .-~ oM .u.u..tioa oL tho dr,.. Tho II!tor
`--... n....t-M ....... ____ "- tho
`pbut.1t d .... ill pOrI, I!>. !ol&tiftI)' ......... of podIwoI
`_11!0 peripbm'ol .... ~L
`1'11-.' lrwt-liDe....nan ...a- ....,. .... ~ ill
`~ ,...-... of pOditoJel Wl<rwiDa: a. 0fI!i
`tho ADVm8B UACT10Nll __ ill ......... m.bIot •
`u""",, iII!uoiOIII of TAXOL 01 de. lrteIo fIl lS$ """ 115
`_81_ ...... '" .....
`"""' ...... ~ ill. PUoo S ~ otuJylll
`....no.. ....... potioaI.o 0IIII 0" 0IIDIJ!IaJ'I... III Il1o *,","".
`_
`o.t_DoU"" ... Pbaoo I • 2 dliIleal
`otudioo (I. potioooIo). 0 . ".1tiooII1or """'-l-d Phuo 3
`...,. (to? ]I!!IloMo~ .. woll .. lUI iIdoria> anaJ,sio "' ......
`ISoo t&bIo I ..... 1
`It ~ !hOI..;th tho Ubout W\ooIoro ofTAXOL, .:10110
`.. I ..... Iet ___ ....... ...,J ill l~ppotI 01 tho _ of
`113 ....... '1 ~
`_
`ill de. 11M..,... _
`TAXOi. ill pOIM" who to... raJW JaiIIo) ,,~,
`tho C-- by t'1'-, wbetMo tho AtIC (~) !""O!!I.Oloo!I __
`-..01'1"..-.01111<_ of tho......,. '!Wool
`~. wltI!.""hour Ial\ooiq!l. "".:IOIIo1aa-oooo
`It. PI.- 2 _
`(82 pOtiom .. ) abllood ... IDotiol_ ol
`bo.de..thoc.._ "UC((J.ooJ_~II,. __
`135 to 1'70 """,,' iD _
`]I!!!la .. (>\lO\I) ~
`appoft!ll YOIu.IIIo 01 <IIouibII(cid:173)
`.... roopooIh-oly, '""" _
`..... 2A houto II,. ..... u.._ ln~. ~ ... \.eO bt
`Z2'1 ... IIU u. •. IDdatil!r ___ _
`tioa 0I1IMo!lJ _
`with tho:u.""",, WIIOIor! oITAXOL.
`....,.d _
`~ __ ...... zn.{_Cl: II ..... 37'-10I>d lO'-
`19K Cl: 1"''''_1_ olOl.!lJ ""..-pIoIo 0I>d IS ......
`culu diotributIoD 0!I!IItr "-" IIiDcIiD( ol pOCti ....
`t Ia l_ bt t:I]I!!tieoo ... ".. -u. d ..... of-.ll
`_iIIu- ___ .. ~thollMoIo,o1
`L· . . . ieo of pOdituoo1 ...... oloo .. oJ,.ooleCl Ie
`Tho pIwu
`adult ....... ]l!!tlnI" who..-r..J olacIo .... of 115_136
`ttoo ..... I .... 1.2 _Il101_'.5-15.1 _
`.... 10IIII U
`..".... ....... 11,- 1"-" ial\oaIoM {II_ ISl. ao-275 !fIIIrA'
`-0.. ~ 6.3-17.4 _M,.,.,.u..~""-u...
`...... by '""""" ~ (D"'~ 0I>d ":ria mp.' F(cid:173)
`to, Uhour ill"- (11.61.) \II PUoo I a 2 0I...u... Vol_
`......r..I .... 1l1 _tho(rup: 0~.1 _tho) 0IIII1609
`lOr Cl.r oM..w-"'diocriboI_ ..... .-ioto<!'Wlth tho
`IIIOIII.ho 1_ l.&...$t.&. _Wl.
`TAXOL ;" po_ .. ..-itI! AII)6- .. 1atoi Ita,.. .. _
`bdUlp ... tho PbOM J .. ...t,. n.. ~!>etlca 01
`'"'" PhaM 3 01....,. bod • bi&<toriol -... ........... ]I!!tId
`tho - , . _ odott olTAXOL, odIIIb!Iotan!I.t _
`..... t " - (US ... n5 """,,') OIIII.wuJoo (3.. .. u.
`bo ....... _
`..........
`"""" lMoaIoII). '""" -.n __ ........ tho to? ...
`ofloloclillllO h ............... 111 JII'OIOiM, .......
`/ .... ~ _
`0.1 .. &0 ICi'IIIL. \rI.
`poW_I _tnolioool ""'Ci<o« _
`tie" _
`IIlHo 19K Cl: Il.ft 10 2O.Ho) wtth .......
`aod eo partIoI _
`DuM.looo of ~ - - . I
`tho IInI 0101 ",_,_&.3 -"'of,...., u-
`dicatetlw~ . . . . . fIldn!(lolooaM:lIIo rw(cid:173)
`_
`'" "-<Id:iat, ruici!IiIoo, ~ .. d;pboiIbydro·
`.u.. !lid .... de<t ptOC.eiB bif!diaa oI]1!!C1Nat.
`21.' _tho~ loIodiaJIliIIIo 10 __ .... L 7 _tho
`(.-.. 0-1 . _ 15.1+ _tho~ NodIu 0In'I'i~0I .... 11.6
`AIIM mu._~011&-:n6 ...... • ' - of
`_ ~ lU-ilU,_u..),
`
`TAXOL _ I· ..... U-hour ~ _ 001_'" ",.
`" - - ...... -u......m...t oM -u... 1iIIIo .. _
`1D!Ilot/ft lin""')' .........,. '" ~ """ ...,...t rr-
`........... tho 4 __ .... po. iIo tho ~ tohIo.
`,.-. 10 11ft '" tho .... iI>dlc!Ilmr ___ ...w
`a....-. hi t..]I!! ..... ad .. I~. 226 ... 260..."....
`1800 10I0Io $ Ill .... '" __ I
`Atiol,.. .. to ~ .. p\laMd 11)' tho blfoctoriol
`de. fIlrooliolot!olod TAltOL ... """""" lBfaoIoa.. _
`01
`71 .. 01 tho ~ .... ~ Ia the re.. iIo 120
`~ dulp !Ioo<ribod iIo tho pncoooI. to, _POriaf tho
`..... (IS$ .. 115 ....... "1 irNopocb ... oLlIM _
`_
`($
`"'"'"' uod 14 ...... 1--..1111 tho..n.... 'Ibtol .-etyol
`~!'Mpd ~ _10 101 .. of tho d.-. Pod!(cid:173)
`Co"~_""" _
`_ 1.00_....-.... _ __ _
`of 6t. ol tho odmlalotot.l ~
`_
`- " " ' " 0 _
`
`, .... _ ' .. h.'\. ~ £L io I\!IUIoI' pooriIod 11,..
`BriIW.M,... SquIbb C-PM¥ JII'OIIritWJ_!orin
`
`d
`
`..... Col. fIll'hanaocJ _ Alt;od HooltI! s.:.-.
`tho _I SiIW MocIit:al c...tor.
`--Ot-fCOLOGY PIIODUCI'S
`
`A BriItol·/oIJoro SqIIibb c-pu,.
`~.ru08M3
`U ....
`Ki-800I-3-W
`61-OO1121J.02
`
`:lUIOlM.{16
`___ /lopI.oIIIbot 1_
`
`tho -hI1 oflllktotlabullo &oI!I bIbWiJI !Ii-. oM ....
`lIiliou Idlttobtbuloo by -w.. !ItpoIyIIIeriuti<a Thlo
`otal!IlIqo .."Jto .. II!o Inhlbld!. "'tho ~ d1aoak ...
`~ oltho 1IIlm>tubu1o _
`that 10 _dol ....
`~hol \II...."... uod lllilllllt <ell_ ~ ill oddi ....
`pOdi ... bod .............. ~ .. 'tIuadloo'oI ...... a·
`bulM tJu.ouPout tho..u.,.... 0IIII .. \tItI1)Io 00Itt0 0Imim>(cid:173)
`tubuloo dur\oIc _
`PoI\owioc " ' ' ' ' '_ odmiaIotn_ oI TAW!., poW_
`p1a&ma _tnotiooo !IocIi"..Ila 0 blphuio -.or. Tho
`
`&oI!I __ IIIoa :100 potion .. ......uod ill • u._, ...
`
`~ ;r.
`
`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1008, p.03 of 9
`
`

`

`I82/BRISTOl ·MYERS SQUIBB ONC./IMM
`
`PHYSICIANS' QESK flEFERENCEiII
`
`T.x~nt.
`
`_ ~ '--l aDd tho t-o octMoI .... ~ 01.-0. Plo·
`_ .. .-..u..- 11M 115 . . . • ... hood .... ~ ....
`...... 1e .... 1 fw " - ~.LiC \bot ~ .... <1000: I"
`... H,. (,..o.28~ 1'1'0 dIa..-;" _~ "'to ......
`*1M _ __ parioc 11M $-hour with 11M )4--.. 1alU·
`
`...,.' oITAXOL had • ~ Il_ to ___ u....
`" ' - _""..- tboo 1M ...... ~ _loa U ... 3.1
`
`_
`_11M .... 11 _v... ~. ModIIon ............ w ..
`11.6 _tho;" I* ...... .......r.u.c \bot 175 . . . . . . . 01
`11.0 _1hI ill I*tloo .. ....n-u., \bot I:J.S
`TAJ:OL _
`~ do. (poO.82). w..tiP tun'"iftl ... IL 7 -W ror
`_tho ... peeloeIo~ tho U-bc>w""""" (poOR11
`TMM~""--"-kI1oo~_ .. ___
`_
`01 . . mIIltipIoo __ .....- ......
`TAXOL ........ - . . ;,,1*_ ....... hod ...............
`-...- 10 pIotilo_..w.., Ihorapjr (oIoIMd .. 1 _
`~ while ,"", or t..- .. Lor- witItlII e _w
`__ ..... 0114.".;" tbot ""-'""""" aDd,.,. ba \bot
`fhIm~oI •• pI.otia_ .......... ~_ ..
`
`I'II&M I • 2 dlalcoJ Jl<IdIoo.
`..". ""-- _ I pn>IIt l.. thio PhaM S otud1_ ........
`.... tbot pooIocI ~ 01 010 .. ""'" 812
`_ with tho. _
`~u-.d;" IOdiDkallltucl;oo. n-a.d-. ......
`IlDII """- ...... " - \bot PbMt 3 ..... 1iM .........
`~ ......" .... cIoooribod ia . . ADVEJt8B JtJtAC.
`T10NIJ ~;"W>ulu~8_IO)_.........r...
`
`l.t.Io ~ -,.In It. _
`T .. .,. CI ;1
`1_ ....
`
`..... (pora<I1)
`
`• .... CponwtI
`
`.-.."'~
`.......... <-tho)
`
`""' IL~)
`~
`
`•
`"
`
`lU
`
`......... ~tho)
`
`~
`
`• ,,-...JuabIo I*tloo .. 0IIlJ;
`PfII/IoIoI!cll~ _
`·11.01.-1* ...... _
`
`Sflmu.. ~ ~ hocIy
`
`c, ... ... 1
`
`.... CIopIoLib
`l-z •••
`
`...
`....
`" . •
`. ....
`
`.~
`
`(_ 127)
`M
`
`"
`..
`
`13.0
`
`'"
`
`pI ... ~...nb ~ l"MiIIuI~
`
`~"lfII<,oq In It. _1-..u... o-..r\on ~ SIuCty
`P-'£
`
`..... ,l1li
`
`"""
`
`21.7
`(IU--:!JI.O)
`
`"
`
`(I.8-6.U
`
`(t.G-U.U
`
`(1.7-31.1)
`
`(1.1-4.0)
`
`(U-I4.5)
`
`1U-1-4.fl
`
`10.1
`(1.1- 11.1)
`or ....
`tIta1 -""""'" ~ _ I 01 ... _
`tho ........ c.- $po<ik S)'IDpkaO I<IbocaIo 1'1...-..1
`_
`.... T.\XOt. J.35 ...... /Z4 boar pi ... dopIatilo .... -.parad
`I"KIon, tbtn
`
`14.1
`11.5-23.5)
`
`u
`(3.0"4.8)
`
`• n" (~
`• 11K c.a.s.- In'""<ll
`• ~c.-tlta)
`• 11K c...t.cIeIa lollMOl
`
`......... Il00)
`.\II6'ifo~ In"'ol
`
`0
`
`~
`
`6.ISli
`
`0
`
`,....u..C-tho)
`
`11.7
`
`"J
`
`........ -
`0100: IK YO. I~ (,.0.50). Plo ...... ~ tho 175 ._---
`_11M (po(I.OS)' n.. ~ timoo Ie> - - " " " lOr ~ .. --
`........
`............. IIM S-bour ... <bo~~ >nO '.0 --
`........
`.. -
`• I'N '-I)
`I*~ ....m.., Ibo ........ \afuoioD 01 TAXOL IlDII IU .-
`......
`.... -
`. -
`. .."
`~ ...
`~
`....
`."
`. ~ .. ,.,.......
`...
`...
`..... ~
`, ..
`. ......
`....
`".
`_ ....
`n.. ntIII .. ItI u.. rttodoellild. ttlld¥ ... ppot1 .... _
`ItI
`'U
`TAXOL (p.di\alel) II\joecIoD aI .... <lISS '" 175 ...,r,
`(8.4 ... 140.4)
`cd by • 3-IIot# u.u.- iIII\taiOIt... Tho _
`_"~In_c..- __ 01_
`.• " .. \boo ........ ~ .... 'or all _
`......... ;n·t cd ..,. :u.too.u 1nW ......... __ Icotic.
`, ... ,"'_._01....-n...,.
`• 1"'-1 ............ tluoI¥ _ ~ III .......... tho .-
`~, tho otudy b.d ...... Mdoftt pow .. to daurmboo
`..... ,
`..-t>oII>er • particular ' - - ' odwodulo ~ ..........
`"."
`""-
`.-~ o.c.. rr- 8S ,...... .. --.I ba thno
`...... ~illtholnO_l ..........
`''"''''
`clialc:aI ot_ on- __ '" 1U>d __
`1bo ~ - ' ~ ... l*tIon .. wbo "-"""AXOL
`PbaM2_1oboI ........ 1lDII_471~_ ...
`--...1 with ....... _
`Ur. ................. .-It.b. dap!otl" ba IhIo otud1 w .. ~
`. . . . {...nb o.csp _PIIOf\l .. 20D ~'. Tbo ~ . -
`•
`for Ibo pooled ~ 01 datt
`.....
`_1 ___ ..... ""'*_-.h>cIOd ;"
`_oITAXOLIIoI* ....... wlth_rio ___ ._(,..-l
`rn.. 't2p.tiItIU Il"MI*I with ~1. TAXOL ill 10
`...
`• p-n1 ..
`rn- the _
`11.1 prioBto.~trMIC_ ......... oI_prior .~",~
`3 _liDo NSCLC otud1 .... doKribod ba
`.... -
`d>o...u-al*"li< ........... TAXOL _ .......... town.I ;"
`• IIMIilM t-thol
`\boo Al)nJl8]t 1UtAC'I10NIJ ........ '" tabdW \"hWoo I
`'.m
`_1aboI_ ... ppaot tho _fIlTAXOL ............ 1lM
`11.- .... trialt ... Uhour...,..., '" 1rUIlaI . . . 1tI250
`pe! 12) &ad IWfttrn .......
`AIOS-I\.oIolod ~ s..-: Do\.O "..... , .... Pbaoo 2
`_
`...... ~CII61IoCl:mIo1K)_~:KCtKCl:S2'ifo
`""
`thoroPI' ;" .......... wi'" AmS-nloo.d Kapooi" __
`to T.HI.1 ... ~""Tho thin! " " - 2 otaId:r w" "",.
`dUCled 10 -.r..Il ~ .... potloat:..-Ioo hooI r.u.d ....
`~1tI1IM 86 I*'*>U ItItIIlIod 100 ........... b.od
`.... ~,...;-lortbo ...... _I"'_1It .-..-. TAXOL 1m u.. """'" , rtud)' ... .-.IoIeo1 with
`thnqdla,o ""'P1 IlDII .. 100 hod ~ .............. 01 ",.""-" _ ~ .ttho..-.. _ho ~ •• ~ '-""" . , - .... ".. bachodlnr IaIUletcol
`olpbo (n'ifo). Do~ 01.). DOlCWt (ft) &nd .......
`.... pooled ..w,sIo of 010 .. r;--. 812 ~ rubOc:UI ~ ~Pl' (42110). with 14'1 ho...u..
`.u......"l'bI ..... otTAXOL wu :zoo mrJm· ... 24-bour
`th.ar. _
`b
`IAfItaIooo with G-CSF ouPfOllli. Nt- or 1M 30 1*110 .... _,"-,;" lQdiDkaI_ n -_ ...... \l1lDII 0<1.
`..-...:t prior ... thnqdiDoo. ElIhty·h _ I at .. _
`__ .. fhIm .... Pb.M I __ _ otud1_
`_led I*~" hod - - " ' ........ 0II0d0I DOl 1DIon .. ,
`~.1*tIW_r..'_"'0I3O'IIo(_
`In .......
`-."Ibod m tho AIIVEIIlIZ IlltACTIONB _
`_01 ........ P1."""""' ................... 10_ _
`prior 01* ..... \honpJ.
`~ 1K-6O'ifo~
`_'''--....,...ThIo...u..-w\dIJ .... _
`Ia St.od.t CAI39-17~ ""lila ........... TAXOL at 135 """,'
`.... ~ 8 aDd 11J ud "'rT"MM "'-
`<II>IMd. 10, pa ....... ~ IrMVId 'W\\h _ or .... nrP- _ _ c.- ..-. c..-... /HSCtCl--h, I PI>aoo S
`... I-h<>u. InfIWooo ....,.1 ..... (In....sod _ bI_IJ
`lobo! ~ I'lUIb" _ I IJ Iloo !uIInI eo.
`.a ..... '/woooII:~ II DO ~1iIId~ tazIcity .... ____
`TAXOLot.. _ 01_ 11& . , . , ... 135.,.' p-" --"'"" o.....Iov o-p (E(XlG). _
`lOoI_t......-- Homo,"""""", r-th r-. __ '* ..
`""tleDli __ ..... ~_IO.-...I66 ..... _175 ..... ·"' ...
`I""", ~ In .... 471 1*1loa .. ....uw. _ hod
`........... 1O.;u... TAlCOL IT) 115 ......... U'-<Int!o·
`bo ..-I inllla~ 1m Stad,o CAllt-2111 polin .. N«l"",,,
`_bo ............. will>o::lopIot.inle)U ...... ·.TAXOLITI
`~ ___ with Impaind ~ ......... t
`260 ,.,... .... S4-IIow" InI'uiotm br. ......t.iroOI ... wnII dop!.
`TAXOL (pAdi.."ol) llIJo<tior> .. 100 tf4/ .. ' .. I S-boou
`ItIIdy M\l'J. _ 1~ hod ""-"" -..-..",.. 1*.
`.,..!:l75 mru.ion.....,., _
`(In""'" _ ba~ 60 ..... .,
`au. (oj 75 """,' _
`0-csP ...-.. or cIopIot.Ia.
`ti(Dta bM foUod prior cbnootbonPJ __ ... Ihl ~ ........ doJ" I , rou..-IIIJ oco;ooIdo (VPJ 100
`... ~ I. thio .. udy I*tloo .. -W 100 '-"""'.I: '-'o1OpOi •
`o<ic ..-u. - . _ u.. III" 01 TAXOL IhonPl'. or
`.s..n I, 2, - ' 1 C_l
`. . . . . (IOIo). tho -.utIc totCtitII ()MA or bod> (11"1
`.;....!. """ _,.......mnI .. _ Oft ....... ;" tho roIlowhoC
`thio .. ppon. ...... bo iIUti.c.d ........ tod; u.. ... 01
`~ - ' " 01 .... pootIeoI ....... booII ~ ... ~ ...... ~tiaoo .. ~_r.a ......
`paoocIlO aalhrM,diaoo IlDII 2M> of tI*I hod .u- "",.
`IntMolty>of TAlCOL
`TAllO!. w ...... iDonuooL Tho _
`UlOId II> tbio l*_t __ Ikm .... __ u.._ ba·
`1.a.bIo. n.. npon.o4 ...-J- han _
`IoMa odi'*'"' 10t
`oidond _ . 10 1lIIt .... 01.,.,.,,-
`teooky .......n-..w r... ott- ..tid too--.
`n........u _
`n .. rot tbo.4&4 ..... uabIo pw. ......
`• ... ,ltiplo .... pariooao. "..... ...... 111_111 oipl&atI\
`M(9KCI::r2'ifo...3Ot,l.w!th n .... pIot.o_"~ dI~ fI-u.,..to oI\bot TAllOL pi ... dopIow. ......
`.... ....I moo 10 ______ "..... . . .
`Tho-tJud"",tilmof_ -no! " - .... _
`_
`~ 10. ~ ~ oIN.x..tar f!ou..
`_tho). o...nn ......... 11 potloo. ... u.. II>IIdiI>D limo 10
`tho 4nt UJ' of"",,-.t. _ 1.1 _Ibtt....p: 3..4-11.1.
`...-ticob, I .... tlOXI!4i1. ~ ~ 0Is..
`...... 1lotIaIly ,;p;a....\~ bI .......... ~ 01·
`Ihor TAXOL pi .. cUpIo .... __ Iloo <kp!otiro pl ........
`'I" ... ~1nc..
`AIlI*t>naU II*' wIoIoNprooioi ud poor riIk diIouo. ~
`tsoo ..w. 5 boIow!
`Ibo ACTO WIIiIIr.,;..n.. 10 1* ...... 10 ..;11> prioo" 0JIl0mI0
`diaD...m.-oI w .. 11.1 ~ C _ O-IU_1bt}.
`a..po..o. ...... ~ """;'01 _
`tbonP7. __ __ rial h r_ t oIdiooooo (T,~'"
`I" .... ECOO "udy, .... F-u.octioa.oI " - t 01 c.-
`...:\i.&n Ii-. 10 pm-
`".."..,.tw.r (pACN,) ~ Ir.od _
`h.,t.CD4 ....... < __ ·(I,J._t7'ifobM_rial
`~ ,.. tho 2 . . - Oft ...... ba Ibo WIIIwi"I tabIo.
`ItIbomltt
`~ 1boIr.,........ W-(S,~
`J _u . . r.a.c; SIuCty
`In It. _
`,_ I: IIfIceoy _
`All pot.;oo,u Ito SwdJ" CAI3t-I7~ hod. Kanoc6k;r!*lil>"-
`__ ........ of Sl) or $0 M boooIi.ao; .. Study CAJ3t-211I.
`tboon .... 211 (_J 1* ....... with. Kamo/ioII:;J JIIIfo<-
`A"l"Q or _ M bwotlDo..
`_
`
`"'"'"""""" _a.5 _Ibt{nap: 0.0&--17.1 _tho)._ --
`.-
`.-
`
`.n\l~
`
`• "!lrwfl> ........ on
`...... t-u..J
`
`. .,..,...
`.........
`.... "' ....
`
`• IIMdiaI> (IDOClha)
`·0-__ 1
`
`~
`
`0.12
`
`·_,01,*,*,,,
`~[VPIloo...'at· _
`~ Iodop!-ri....
`
`... min' ...... I.V ... d.o,ro I, 2 mil I-
`· 1
`
`......
`'00'
`"
`'.00
`..
`"
`
`n ./U
`<n
`
`""m
`<n
`l...zo. )
`
`U
`<0.001
`
`U
`.~
`
`10.0
`
`••
`
`~
`
`T_ .. ' - - " ' - . II $tudy l--,
`
`_W
`.n
`
`,-,
`"
`,.
`..
`
`U
`
`"'-"'" 1: ....... :r. .... ...
`u... _l1mplo ....... """::
`
`-
`-0nI:r. ... _
`
`0..-"",
`
`-",p-
`--
`I"iiii' 'i'
`..
`.-
`..
`,
`"
`
`Apotex v. Abraxis - [PR20 18-00 151 . Ex. 1008. p.04 of 9
`
`

`

`~~--(cid:173),-
`• M » • •
`.....tioa tI.o 10 ............... 8.2 _1_ Cl: 4.810
`
`.,..,
`
`..
`
`.,."....
`
`I ~"""·
`PIlECAtmON!l
`
`..........
`
`PRODLICT IJIIFOAMATION
`
`Altboucb u.. ...... _~ io:I u.. _1Wdloo_
`oIithIlJ' _
`(46 .... _ ; " Stud7c..u .. 114 ad
`ao ... ''''''' ill Sco>oI1 CAJ.3I.28I), dooIi __ iD_
`~ .... :s&49 .... "-It ill boob owdioo. .nth • -...oar
`
`"' ..
`
`~,
`
`1_1: o..r.I ... , " - -~ ACTa ~
`
`Tho.....u... tI.olO_ ...... 1 WMkoad ..... .....tioa
`d ..... 1iooI ot __ - . .d r... ..... k Ny otlteM-
`_I ... lOA _tho (_e!: 7.0 10 11.o.-tho) lot .....
`~IO ..... bIId ~ ~.,.-lc:"""""" Tho
`
`8.1_IhI~
`.. 1[ ... UIO "" po~ Modi
`~ CIWuI.
`____ ~ (pI&ao .... oudo~_
`"'" Iood ..... ill ..... ,,""" ~ N....u..-. cIiadI
`deooriptl ........ pboIOvopho iIodic.oWd ...... bondt ill
`pot.leatt.. bod...un, ~ "'_--. ~
`_
`rw..tIoo. ill potloQIO Wlih puJ.-..y ~1. Il10 __
`ambIoLolLoG, ...t1>\ioQ ot ...... ODd ........ ..wp.ic
`~to .. potIoDtow:ilhK8i11 ........ tho""ad .....
`oId_ of. ffociaI ..... ud . . . IB posloatIwith K8 ....
`ooM.,.wto..~ud~.
`-,.....",. ___ I p«i6It oITAXOL ~
`10 po_u 1ritb ......... HN dlooot..o ad _rillr.AJD$..
`oelor.od ""pooI'o .............. -'11_11f IOIhaI _
`III I pooItd ....tyo.It ot da .. ".. 812 po_to wilh..ud ....
`-. n- ""'- _""",, __ to !'rom .....
`",... 2 -'"liM Ka_"._ IWdioo ..... ......nbooI
`a oad (3) ud .......u.-. ..... ill IhlI """'_w-d
`do tho ADV£JWI: .Il&\CTtOSS....., III IIbooLv IT\IbIeo.
`,.. ................... _
`.... , • ___ ""--"' ~ of
`T.UOL """ ... PfI"F'lWt ......... 1')" bod...tillc ....... topoiotIe
`FOWIh r-;" po_to willl __ ~ ..........
`--""'- Paliato with AlIlS-Nb,"",..Ito"""'""'(cid:173)
`_
`hit ... __ ~~tIoI t.b.M potlottto
`wItIooolicl ........
`INDICArlON8
`TAXOL;' lDdieotad .. 1 ..... 1iM and ",,'-'-I thent""b
`tho ~ ot~ ..m-oottho .....,.. AlIIn&(cid:173)
`liDo u.r.py. TAJ[OL itt iadico .... ill __ willi ciopI.
`~
`TAXOLIl IacIic:alIIII b ..... --..,ot"'-'_ a/Ier
`I'aIlun ot ........... tIoa ~'" tot _ t i e ......
`.~witbbo8_""'ot~,~. PrIor
`thoftv.r -.w 110 ... IDdIodod III III~ ....- d ....
`;..n,-~
`TAXOL, ill -anatloa wilh aopIalia, io iP<IiooIOOI .........
`IIn&-fuwt u._,ot_-u..u 1 __ 111 po&ioot.o
`who ItO "'" ......uUIM lot ~ ..... tl ... ... .....,.
`....vor radiatiod ........ ""
`TAXOL .. iadicolH .... Il1o _ _ Haot u._, ot AIDS-
`oelolH Kapool"o_
`CQ.'ITRAINl)ICATlON8
`TAXOL II _""""",,"ud ill pou.u. _ho """ I"...,. ot
`~ __ IOTAXOL._cInop"""""
`~"'~KL {~,"",_\IIIl.
`........ ill po';"'" willi ..ud ......
`TAJ[0l. ..bouId _
`..... hit .. bo.ooIU>o _"""'Phil ........ ot < 1600 .. Ilohuo' .
`iD po .... to .nth All)S.oelo" Ka,... .. _
`1ritb ......
`liM M\ItrCIIIhll ....... to eI < IIXIO .. IlMu:t' .
`lOriood b)'..,._ ..... ~ ......,w.,: ..... _
`.~'" ~oad_~ __ m..(cid:173)
`
`~ ..... ~uticario 1Io .. -...-I1a
`K-tt. <II peeioDIo .......... TAXo!. itt d:iDi!::aI trialo.. F, taI
`.......... """ CIO<IUTOd iD po.~ cIoopt" ~_
`All po.tIealo obouIII ... ~ with ~ .u.
`~. oad 112 ""...,.;oc.. (500 DO&\GEANI)
`ADIIIINl1rrRAI10N _
`) ~ wbo _ _ _
`__ hn--\&m17 __ ",TAXO!.oboWd ""' .....
`.... 1loqoo<I -til> Il>o .s..,.
`s- ......... ___ {primariI, ~ Ia do..
`m.....,..,.. .. ~ "'""'*' eI U .,.. TAXOL obouIII "'" t..
`..... _oadiolllo~~~ ...
`+-;aiPom' 10 poeioau .-jib ...... -.,IW _
`eI
`_ .... 1500coIWmm' (<JIXIO...a...,.· .... po.Wau._
`KS~ " ' - ' ~ .r Wood _10 oboWd bo lam.
`""'" cIo.uiac TAXOL u._t. Po ...... oia>ld ........
`___ with ~ Qdoo otTAXOL .... ti1 _h-OPhilO
`
`SRISTOL-MYl:RS SQUIBS ONC./IMMA83
`
`I [ OoatiD_....u.._
`TAXOL .......... '"
`l~io ... ~ ....... pWooo"..ttb _ _ •
`"""'-'-...........w.. (Soo WAIlNING8 _
`__ '''''-= ~ tho -=- eI poripMnl
`J
`~ 11 e..r-t. 1bt dm.~ of ...... .,.II"
`-..Iop-;' .... .-1 oad ~ ..... '"""""""" "':lOt.
`... all ~ ......... elTAJ[O!.
`TAXOL ~ ~ olaIboI usP, 3M """,,,,_ •
`......... obouJoI "" p.... 10 ~ cr."!! ..... oIhott&cQ
`'" oIoooW. (Soo PltECAU'noNflo ,_ lIM - . ,
`Hopodo: ",.", io...w-. tho. Iho 1II:ItXi.,. otTAXOL Ia_
`eo"",",,
`""-<l ill po. ..... witb _.10<1",""" _
`_ b o __ ~TAXOL ... po.""'''
`......... " to _Ioopotle ~I ......... odo
`_
`~toal>t>o>ldbe_
`.....-. SIll __ . - oi .. __ 1Iod...un,
`..-...............,10 __ ............ ...aIl7mildoad
`~ "'..,.u.. ..... ...w-. okUt ~Itiod..
`....u;.,. .. tho~ oit.o. n- ....... ba ............
`......... _1toquatI1l1 willi ..... Uloow-~ t.b.M 1ritb
`..... ~, ~~o£okUt __ ... oiteot
`-""'" - . ........ JoIlowUIc ~tioa. elTAXOL
`It. ~1""'1.e.. -.....n". baa ..... -'""' ~
`Rat. repor<o "' .... __ ...... 11 IIICb • pbJoI;riIia. cti)g.
`
`Ii.tio. 1Dd.,... &kill ozIaIIotiaD. .....- oad lbrooio htt ..
`....... . -............ rL Iho ... n"""" .urwwilIaDce •
`
`TAXOL .... ,.ltr. _ _ tho _
`ellIIo iI\IOctioa. oilo
`-..tiao. ........ CIO<IUTOd dllriDc. ~ Iahoiao ........
`~""._IO_<iI1t-
`A~UMImOrIllot ...... _
`...... .-.loaaiotlJlbowo
`" <hilt tI.o. c.-, Iloo~, otmn ......... it II. odo
`. -.. .....,..; .... tba ___ ... ~l:tII .
`........tIuriIIe" .... ~
`c.. d
`i ..... " i '.........- rL "-tIIIIy: TIM
`~.-..Iial elTAXOL bao ........ otudoad..
`Podi"""; boo ................ ~ ~""'" (choa.
`obtnuIoao iD h ....... ~ ..... "' _
`_
`(mIeroa ......... \to""1 J>odo......t WII "'" ""' ........ ..
`""'~ .... _ olooCHM1CPRT ....... c.tIooo_
`~eI~prior"'udd...u.lIIIIirtc _
`"""-I ~ otlonllill" .ala ad __ .... It
`" - ooq»al ...... __ shu. 1 ~ (aboao 0.Ot .....
`daIIJ ...n..v... ___
`I I bw:twI .... "" I mFo' M-
`olo). A. IhlI .... pot:b./.u:IoI.......d ...t-I ro.uIiI, .......
`~:;t: -!~-...,...oad-..;a\$
`"....-r. "'"--- 'Ca~ 0'. (Sao WAilNINC8
`
`-'"'J
`....... _ I . ;.""'kDow .. _IIIottr.,.io ...
`<rotarI III ~ ........ milL FGIIowiq i I I , , - IIIImiaiot.-.(cid:173)
`.... of -'-·14 IaboIod TAXOL ....... u,. .... 10
`~ itt ~"= ~ ~ ;:':":'"!III-::
`pI-.._.....-._ ........ .u-... .....-iII
`
`b ......... mIlkoadbora.-ellbo_tIaI ... __
`___ ill.".... ittfazI ... it io --..dod tbat~ ....
`.... boo~'" willi> ...... q-TAXOL ....... py..
`1'lIdII1tIcUM: on..~""" .....
`otTAXOl.lot .....
`1IiMri<.",,~ """ _
`...... ~
`",... """ ...... ..,...u ot _tnI __ IJICaO \CN:S)
`IaIidr;:r InRb -..... with -.w lot • <IiIIdl trlalia
`podiatric po .... " ... _bidt. TAXOL _II Uo!uood btIn_
`~_a '-n ....... ....p.,.&oaoao ... • ... dO
`IiUb ItInb<ttablo .. 0100 hiP
`...... • TIM IIIIdo>\1 .. _
`.... <110100 MhII>oI-, 01" tho TAlOl. ....... ......
`• ohon iIIt.Ioa ~ on.. _ eI ~ ... olbio-
`_
`....... ta01 ~tltio ..... ~.<Iin<I; .... ot
`0100 padito.ul i!Mlf ................... "'" ..... ~ ......
`..... II> tbIo M>Mb' <- Iwioo 1M .---.locI ... "" ....
`..->""'" II. _
`iD .......... lbo..rooy elTAXOL
`.... _
`.. tbIo popuIItIoao.
`
`ADVB:R8I R&\CT10NS
`_-"'''_E_~'''''''''''''''
`"-"' s..- Duo ... tho IoIloooiIoc \IhIo ....... "" .....
`- " " - otaU ~tloaiI (493 willi ..-.rIll> ~ ""'"
`~......u.cI1II 10 IWdioo no ..
`lUI with _
`..o..d ~I TAXOL(pocIilopi}1JoJ,KtiaL Tw<o~ .....
`dnd IOIId _I.r.& ... """",to_ u. .... In I/PI. ~ 2
`IlUdIooo willi TAltOL ...... ....,u,. ".. lSI! 10 JOO .....
`ltd _:u batoro (II> lOur "'~ otuoIlao, c-csr
`Id • ·d
`w .. ~ II httmltopaiMl< ... ~ ThnIo b",,·
`_3~..m-ttudy_......,..""' .........
`dnd ..... _
`"" ..... " ..... IrUIId In ..... .....s...u.d
`(1M ... 115 .... '1 oad two..t.odolM (3 ... :u bouto) eI
`TAXO!. Tw<o ~1IIOdrId oad 1lIlrI1_ ",,-to willi __
`caniDom.o __ TAXOL {1M ... 116 mFo'J ...... D;..
`...... _ S bouro ... I ............. ..,..
`lSM ubIt I.~ lop elnat PIIII
`N_ eI tho ~ IOOdeitiao WI .. <Iooub" ittlI __ ""
`
`-OIM,_ipMlk - . . . Eo..,. ~ AtaI·u ...
`
`Ow", 1ft ~ r ... 1M 40i ,..tiI~1o _ho .....
`.....Ju.IIIIIa Iot..r.tr lot tho 1'11.-" 1lta-liM........,.-wna.
`tlort ~ otIICb'. tho r.Ilow!Ioi: .. Il10 obow1lbo ~
`otloo...,...... __
`[Soo tobIo 8 "" _ ~
`~ o...r,: F. tho ........... who ...............
`~I TAXOl. !paditueU ~ ill 0100 _ 3_
`"""'liDo _...a-.... 0100 IoIlowq Iablo obow1
`lbo ......... ot~ ___ ___
`ea6J eon __ _ _
`[Soo tobIo 10 ... _
`
`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1008, p.05 of 9
`
`~I ... _ - - - ... _ - - -
`
`

`

`_ " -..yo .. __ E_ I r I '_ WIlt> 1eIoI-n.-1IMoMoot iii. • .• ontTAXOI..
`
`PHYSICIANS' DESK REFERENce.
`
`_ .. -_.
`
`-~--...
`.""""",,.. ,
`,11 .... "'"M, ___
`--" --,
`
`100_ -n.... •• _ _ ~ ..... (J1!I:I
`II.; I pp """~~_ ... ...
`.......... Ilot ... f1I . . . . •
`NSC1.CIrlCo obIo.M.
`III"""....,. .........
`_
`.... 1M __ o.op.. ...... ~ a.-p (EIOOO~ ...
`•
`, Coo...
`1Ioeu_..........u.d .... IhotTAXOLm 135 . . . • .. .
`:u"-"Io.."""""_~_ ......... (el7l . . . •.
`• VRaI Sip a.....o'
`TAXOLCT 2110 .............. ~ 10 -"'-"'"
`-~(N..m

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket