throbber
PDR”
`
`53
`
`EDITION
`
`1999
`
`www.pdr.net
`
`PHYSICIANS
`DESK
`
`REFERENCE
`
`AstraZeneca EX. 2046 p. 1
`Mylan Pharms. Inc. V. AstraZeneca AB IPR2016-01325
`
`

`
`
`
`For healthcare information
`you can trust
`
`visit us at
`
` i PDR? GettingW/ell Network
`ii ww.gettingwell.net
`
`Reliable answers
`to your important health questions
`from the publishers of PDR®——
`the source your doctors have trusted
`for more than 50 years
`
`Comprehensive—Eclsy—’ro—use
`and Absolutely Free!
`
`Based on the PDR Family Guide Series
`
`Brought to you by
`‘-1 Medical Economics company
`
`Astrazeneca Ex. 2046 p. 2
`
`

`
`

`
`
`
`
`
`Keep Your Entire Drug Reference Library Completely Up-To-Date
`With These Key Volumes
`
`
`Revised!
`
`
`V
`
`f ,000 |rages!5 '
`41101] []|1](J;!
`0vur 2,[lll[l
`color photos!
`
`Tl|_9_
`rlclrnrlrve
`|_||0}"C?'|
`rlrclrormry
`
`Newly
`
`1999 Physicians’ Desk Reference®
`Physicians have turned to PDR for the latest word on prescription drugs for over 50 years! Today, PDR is still
`considered the standard prescription drug reference and can be found in virtually every physician's office,
`hospital, and pharmacy in the United States. The 53rd edition is more than 3,000 pages——our largest edition
`ever! And, a new manufacturing process has increased the margin width, thereby dramatically improving
`readability. PDR provides the most complete data on over 4,000 drugs by product and generic name (both in
`the same convenient index), manufacturer, and category. Also, product overviews that summarize listings with
`more than 2,000 full-size, full-color photos cross-referenced to complete drug information.
`
`PDR” Medical Dictionary
`More than 100,000 entries! 1,900+ pages include a complete medical etymology section to help the reader
`understand medical/scientific word formation. Includes a comprehensive cross-reference table of generic
`and brand—name pharmaceuticals and manufacturers, plus a 31-page appendix containing useful charts on
`scales, temperatures, temperature equivalents, metric and SI units, laboratory and reference values, blood
`groups and much more.
`
`PDR” Companion Guide“
`Fonnerly PDH Guide to Drug Interactions. Side El/em. Indications. Contraindications
`
`Now revised and renamed, this unique, all-in—one clinical reference assures safe, appropriate drug selection
`with nine critical checkpoints: Interactions Index, Side Effects Index, Food Interactions Gross-
`lleference, Indications Index, Contraindications Index, Off-label Treatment Guide, Cost ol Therapy
`Guide, International Drug Guide, and a Generic Availability Table showing forms and strengths of
`brand—name drugs dispensed generically. This time—saving complement
`to your 1999 FDH, PDH for
`Nonprescription Drugs and PDH for Ophthalmology, will soon prove to be indispensable.
`
`1999 PDR for Herbal Medicines
`The most comprehensive prescribing reference of its kind, the PDR for Herbal Medicines is baser
`upon the work conducted by renowned botanist Jderg Grlienwald, Ph.D, and the German Federal
`Authority's Commission E, the governmental body widely recognized as having conducted the mo
`authoritative evaluation of herbs in the world. Entries include: the pharmacological effects of ea
`plant; applicable precautions, warnings, interactions and contraindications ; administration and
`dosage; adverse reactions and overdose data; plus much more.
`
`1999 PDR Atlas of Anatomy
`The PDR Atlas of Anatomy provides an innovative and unique visual representation of the human bod‘
`includes hundreds of full-color illustrations and photographs that present anatomical structures and '
`interrelationships clearly and precisely, numerically labeled for easy use~in practical examination revie
`
`1999 PDR for Nonprescription Drugs and Dietary Supplements“‘’
`The acknowledged authority offers full FDA-approved descriptions of the most commonly used
`medicines, four separate indices and in-depth data on ingredients,
`indications, and drug interact
`Includes a valuable Companion Drug Indexthat lists common diseases and frequently encountered
`effects, along with the prescription drugs associated with them, plus OTC products recommender
`symptomatic relief. Newly expanded to include a section on supplements, vitamins, and herbal reme
`
`1999 PDR for Ophthalmologyi’
`the eye-
`The definitive reference filled with accurate, up-to-date information specifically for
`professional.
`It provides detailed reference data on drugs and equipment used in the field
`ophthalmology and optometry.
`its comprehensive coverage includes lens types and their use
`specialized instrumentation... color product photographs. .. a detailed encyclopedia of pharmaceutics
`ophthalmology... five full indices. .. an extensive bibliography... and much more.
`
`
`
`
`Library NOW! Enclose payment and save shipping costs.
`
`33
`$
`$
`$
`$
`1:‘
`$
`$
`$
`33
`
`copies 1999 Physicians’ Desk Reference............................................................................................................................................................................ $79.95 ea.
`(P9)
`copies 1999 PDR for Ophthalmology..................................................................................................................................................$51.9S ea
`(09)
`
`copies 1999 PDR for Atlas of Anatomy
`........................................................................................ $54.95 ea.
`(AT)
`copies 1999 PDR for Herbal Medicines
`....................$59.95 ea.
`(HM)
`copies PDR Medical Dictionary ..........................................
`..... $44.95 ea.
`09)
`copies 1999 PDR Companion Guide ......................................................................................................
`.$57.95 ea.
`(G9)
`copies 1999 PDR for Nonprescription Drugs and Dietary Supplements
`.$48.9S ea.
`(N9)
`PLEASE INDICATE METHOD or PAYMENT:
`Shipping 8: Handling
`Payment Enclosed (shipping 8: handling FREE)
`38188 Tax (FL, GA, IA, & NJ)
`I Check payable to PDR El VISA D MasterCard
`Discover
`American Express
`Total Amount of Order
`
`Account No.
`
`
`
`Name
`
`
`
` Address
`
`Signature
`
`city/swmrp
`
`El BILL ME LATER (Add $6.95 per book for shipping and handling)
`For Faster Service—FAX YOUR ORDER (515) 284-6714
`Do not mail a confirmation order in addition to thisfax.
`
`
`
`Mail this order form to: PDR, P.O. Box 10689, Des Moines, IA 50336
`Validfor 1999 editions only, prices andshipping 6 handling higher outside (is.
`
`
`
`Astrazeneca Ex. 2046 p. 4
`
`

`
`
`
`
`
`Retrieve Vital Drug Info FAST
`
`Compact! Comprehensive!
`Easy to use!
`
`Actual size: 5 1/2" x 3 1/2" x 1/2"
`(Operates on standard AAA batteries. 72-month limited warranty against manufacturing defects.)
`
`PDR quality and reputation now available wherever you are, whenever you
`need it.
`
`The compact Pocket PDR fits in the palm of your hand, yet delivers instant access to PDR
`data anywhere you need vital, up-to-date, FDA-approved prescription drug information
`instantly. At the touch of a few keys, you can immediately call up the full text of six key
`topics for every prescription drug fully describ d in the 1999 PDR and PDR for
`1
`
`Ophthalmology? .
`
`R
`
`Ouickly check and confirm information about:
`
`0 Indications and Usage 0 Contraindications 0 Warnings 0 Dosage & Administration
`0 Adverse Reactions 0 How Supplied
`
`Now, a new generation
`
`And now Pocket PDR is even better than ever. The new unit includes numerous technical
`improvements:
`
`0 Larger, easier-to—read 8-line screen provides access to more information at a glance.
`
`0 Uses regular AAA batteries for power, rather than expensive, hard—to-find lithium batteries.
`
`0 A hinged, durable lid includes quick access instructions printed on the cover.
`
`The 1999 Pocket PDR DataCard compresses the equivalent of 2,000+ pages of the 1998 PDR
`and PDR for Ophthalmology into a remarkably compact data card. Ordering the all new
`1999 Pocket PDR Digital System guarantees you access to the same quality and reputation
`you've come to expect from PDR -~ up—to—the-minute FDA approved information on thousands
`of prescription drugs from more than 250 drug manufacturers.
`
`Snap another DataCard into the second access port, and you can instantly call up the
`complete text of a second key reference. Select from a number of DataCards:
`
`0 PDR Drug Interactions (NEW!)
`0 The Merck Manual, 16th Edition
`0 The Washington University Manual of Medical Therapeutics, 28th Edition
`0 Harriet Lane Handbook of Pediatrics, 14th Edition '
`0 Griffith's 5 Minute Clinical Consult
`0 Stedman's Medical Dictionary, 26th Edition
`0 The Sanford Guide to Antimicrobial Therapy
`0 Martindale, the Extra Pharmacopoeia
`0 The Medical Letter® Handbook of Adverse Drug Interactions
`0 Harrison's Principles of Internal Medicine 14th Edition
`
`The POCKET PDR measures just 5.5" x 3.5" x .5" and weighs only 7 oz.
`
`To receive your P0(.‘KET PDR, use the convenient order form below, call tall-free, or fax your order today!
`
`POCKET PDRP ORDER FORIVI
`PLEASE INDICATE METHOD OF PAYMENT:
`El Check payable to PDR
`VISA
`| MasterCard
`
`Price
`
`
`
`Discover El American Express
`
`
`Account No.
`Exp. Date
`
`
`Phone
`Signature
`For Faster Service Fax Your credit Card Order Today: 1-201-513-4956
`or Call Toll-Free 1-800-232-7379 Do not mail a confirmation order in addition to your fax.
`Payment required prior to shipment. Prices and shipping & handling higher outside Us.
`
`~
`
`Narne
`
`Pocket PDR and 1999 PDR DataCard (available February 1999) ..........................$229.95
`Other Datacards (available in 1999)
`1999 PDR Datacard ...................................................................
`__ PDR Drug Interactions and Side Effects (NEW!)
`
`_ The Merck Manual..........................................................
`? Washington University Manual of Medical Therapeutics
`_ Harriet Lane Handbook of Pediatrics......
`? Martindalez The Extra Phan11acopoeia..
`_ Stedman's Medical Dictionary ......................
`__ The Sanford Guide to Antimicrobial Therapy..
`_ Griffith's 5 Minute Clinical Consultant....
`: Handbook of Adverse Drug Reactions ..
`_ Harrison's Principles of Internal Medicine Companion Handbook....
`
`
`
`Subtotal
`Shipping and handling
`Residents of FL, GA, IA and NJ, please add sales tax
`Tom 3
`
`$6.95
`
`Address
`
`
`City/State/Zip
`
`Detach along dotted line and mail in an envelope to: POCKET PDR, Five Paragon Drive, Montvale, NJ 07645
`
`391900
`
`Astrazeneca Ex. 2046 p. 5
`
`
`
`Oty.
`
`Item
`
`IIIIIIIIIIIIIIIIIIIIIlIIIIIIIIIIIIIIIIIIII
`
`

`
`
`
`
`
`PDR® Electronic
`Library” on CD-ROM
`
`Speed diagnosis and prescribing
`with fast, flexible access to the
`medical references you need in one
`fully integrated system.
`
`PDRE
`Electronic Library
`
`PDR Electronic Library on CD-ROM is a Windows-based system
`that instantly gives you all the information you need from the most
`current editions of Physicians’ Desk Fleference®. This powerful
`system lets you look products up 7 different ways—by brand
`name, generic name, manufacturer, therapeutic class, indication,
`side effects or drug interaction. The system also includes a powerful
`multi-drug interaction screening module. (Institutional version only)
`
`Choose from these optional best selling titles
`available on the PDR Electronic Library CD-ROM:
`
`
`
`-
`-
`_
`-
`\
`The Mere!‘ Manual‘ Th_e most Wldely used rpedlca! text In
`the world integrated with PDR and Sted man s Medical
`Dictionary.
`
`Reviewing the full prescribing information for any product alongside
`available productimages and chemical structures is a snap with the
`new VI/indows version of PDR Electronic Library.
`
`Stedman's Medical Dictionary. The most comprehensive
`medical dictionary available fully integrated with PDR and
`the Merck Manual.
`
`Stedman's PLUS Spell Checker. 300,000+ medical and
`pharmaceutical terms added to your word processor's
`spell checker. (Not available for free trial.)
`
`Equipment Required: IBM PC compatible computer, MS Windows 3.1 or higher, 8MB RAM, 10MB available on hard drive, VGA color monitor; Double-speed CD-HUM drive.
`Provided under terms of one-year sing/e-user license agreement. Institutional version includes multi-drug interactive screening module and two updates.
`
`Electronic PDR® Order Form
`
`PLEASE INDICATE METHOD OF PAYMENT:
`...$595.00 ea. $
`__ PDRP Electronic Library'“(|nstitutional version).
`..$195.00 ea. $ j — check payable t0 FDR
`_ PDR‘° Electronic Library"'(|ndividual version).....
`......$99.95 ea. $
`VISA D Mastercard
`_The Merck Manual .......................
`.....$79.95 ea. $
`__ Stedman's Medical Dictionary...
`__ Stedman's PLUS Spell Checker......................................................................"$99.95 ea. $
`
`
`
`
`
`
`..........Shipping and handling FREE
`Please add sales tax forthe following states: FL, GA, IA, NJ ................................ $
`Total Amount of Order S
`
`Please indicate version required: I] MS windows 3.1 (16 bit) El MS windows 95 or NT (32 bit)
`
`I]
`
`I'm interested in infonnation about the networking capability of PDR Electronic Library.
`
`Please call me at:
`
`_
`For Faster Service——cALL TOLL-FREE 1-800-232-7379
`OR FAX YOUR ORDER (201) 573-4956
`_Do not mail a confirmation order in addition to this fax.
`
`Account No.
`
`' Di5°°"e’
`
`America” Express
`
`Exp. Date
`
`_
`Ph°”e
`S'9”"m"°
`Prices and shipping & handling slightly higher outside MS. and all customs, duty and other taxes are
`customers responsibility. We cannot ship to PD. box numbers.
`
`Name
`
`Address
`
`City/State/Zip
`
`Detach along dotted line and mail in an envelope to: Physicians’ Desk Reference”, Five Paragon Drive, Montvale, NJ 07645
`
`Astrazeneca Ex. 2046 p. 6
`
`

`
`EDITVION
`
`
`
`'
`'
`Medical Consultant
`
`Ronald Arky, MD, Charles S. Davidson_Pr’ofessor of Medicine and Master, Erancis Weld Peabody Society, Harvard Medical School 3
`Vice President of Directory-Services: Stephen ‘B. Greenberg
`» Director of Product Management: David P. Reiss
`'
`‘
`- Senior Drug lnformationvspeciallst:Thomas Fleming, RPh
`Senior Product Manager: Mark’A. Frie)dm7an.
`Drug information Specialist: Maria Deutsch, MS, RPh, CD
`J IAssociate Product*Manager: Bill Shaughnessy
`Editonvspeclal Projects: David W. Sifton
`,
`1
`'
`Director of Sales: Dikran N. Barsamian
`v
`*
`Vice President of Production: David A. Pitler‘
`r National ‘Sales Manager: Anthony Sorce
`Director of Print Purchasing: ‘Marjorie A. Duffy
`Na“°"3'. A¢°°l"lt, Manage" D0“, B|’UCC0|el'i.
`‘Director of Operations: Carrie Wi|liam_s
`I
`A¢°°“'.‘.t Maflagefsl‘
`.»
`,
`Manager of _Production:.Kirnberly H. Vivas »
`. Marion Gray, RPh
`Senior Production coordinators: Amy B. Brooks, Dawn McCall
`Lawrence C'*Kea'y
`Production coordinator:'Mary Ellen‘R. Breun
`v
`—
`é%f:{:t);.);;1::°'\?_| Schmidt‘
`" PDR Data Manager: Jeffrey D. Schaefer
`V‘
`“Stephen M_’3'nVerberg‘
`Senior Format Editor: Gregory J. Westley I
`.
`'
`V.
`.
`Suzanne E. Yarrow,- RN
`Index Editors: Johanna M. Mazur, Robert N. Woerner
`National sales. Manager, ‘Trade Group: Bill Gaffney
`'_ Art Associate: ‘Joan K. Akerlind
`'
`J
`Director of Dlrect.Marketing: Michael Bennett
`Senior Dlgital~lmaglng coordinator: Shawn W. Cahill
`Direct Marketing Manager: Lorraine M. Loening
`-. Digital imaging coordinator: Frank’ J. McElroy,
`lll
`,-
`.-
`-
`v
`s
`Promotion Manager: Donna R. Lynn

`.
`.
`‘ Electronic Pubilshingflbesigner: Robert K. Grossman
`
`Director, Professional Support services: Mukesh Mehta,_RPh, “ Fulfillment Managers:‘Stephanie DeNardi, Kennethvsiebert» ‘
`
`,
`‘
`
`‘
`
`‘
`

`
`1'
`
`gs
`
`‘.
`
`.
`
`‘
`
`ft
`
`.
`
`1
`
`.
`
`'
`
`‘
`
`\
`
`~
`
`A
`
`'
`
`_
`
`V
`
`_
`
`-
`
`,
`
`'
`
`-
`
`’
`
`/ -
`-
`
`A
`
`.
`
`r
`

`
`7
`
`J
`
`V
`
`'
`

`‘
`’
`
`s»
`
`_‘
`
`_
`
`-
`
`-
`
`‘
`

`
`‘
`
`,
`
`,
`
`/
`
`v Copyright © 1999 and published by Medical Economics Company, Inc. at Montvale, NJ 07645-1742. All rights reserved. None of the content of this publication
`_ I may be reproduced, stored in a retrieval system, resold, redistributed, or transmitted in any form or by any means (electronic, mechanical, photocopying, record-
`‘ ing,‘ or otherwise) without the prior written permission of the publisher. PHYSICIANS‘ DESK REFERENCE’; PDR‘, PDR For Nonprescription Drugs”, PDFi For
`' Ophthalmology”, Pocket PDFP, and_The PDFi° Eainily Guide to Prescription Drugs® are registered trademarks used herein under license. PDR Companion Guidem,
`_ PDFi“' for Herbal Medicines”, FDR” Me_dical;,DictionaryT"', PDFl°j Nurse's Handbook”, PDR° Nurse's Dictionary”, The‘PDR° Family Guide Encyclopedia of Medical
`. Caren", PDFt°’Electronic Librarym, and PDFP Drug Interactions, Side Effects, Indications, Contraindications System"“ are trademarks used herein under license.
`
`'
`
`‘
`
`~
`
`r
`
`Offlcers of Medical Economics company: President and’ Chief Executive Officer: Curtis B. Allen; ‘Vice President, New Media: L. Suzanne BeDel|; Vice President, Corporate
`Human Resources: Pamela M. Bilash; Vice ‘President and Chief lnforrnation Officer: Steven M."Bressler; Senior Vice President, l-‘lnance, and Chief Financial Officer: Thomas
`W. Ehardt; Vice President, Directory Services: Stephen B. Greenberg; Vice President, New Business Planning: Linda G. Hope; Executive Vice President, Healthcare Publishing
`and Communications: Thomas J. Kelly: Executive Vice President, Magazine Publishing: Lee A. Manisca|co'; Vice President, Group Publisher: Terrence W. Meacock; Vice
`President, Production: David A. Pitler; Vice. President, Group Publisher: Thomas C. Pizor; Woe President, Magazine Business Management: Eric Sch|ett;~Senlor Vice President,
`Operations: John R. Ware “
`s
`g
`‘
`V
`-
`:4
`,
`'
`'
`
`®Printed on recycled paper
`
`'
`
`_
`
`'
`
`_
`
`,
`
`‘
`
`‘
`
`‘
`
`I
`
`'
`
`‘
`
`ISBN: 1-56363—288—8
`
`
`
`Astrazeneca Ex. 2046 p. 7
`
`

`
`
`
` in this, thefi
`
`;-:l_r’_lc’i't'jVrhore._L’A
`‘i’_ yearfbr"*th'e ‘2(5tii'centur$/,AifVP‘D:R_i's:‘;pr__f;>ug:I
`.'\
`-4‘!
`.~
`7
`‘tie
`'
`to present“'~its larges
`reflecting-"“overV
`‘_remejdies.;_ .
`
`
`V:A'.l;lf=.yoi,if.haven't;aIready.:.encounteredtatflcopy, you .shoii|d::
`_
`p~
`,al$0_;taKe a‘~;l.oQkt.at_Fhernew:.PDR.Companion;GuideW;.<v.-~
`to annvouncég‘.3[H‘é.‘:ir;frOaudi6fi.,.o
`..
`~
`....'ld‘m'ii°“T.-il”i'
`.
`.
`.,
`an ,1_,>800-page-aarefere-nce.that. augments PDR,;with.:a-A;
`needed adjtinct: the new PDR” fo"r’ Herbal MedicinesW.l‘ '
`'
`
`
`
`.
`
`'
`
`
`
`
`
`“ ‘
`
`‘
`
`Herbal remedies ’a’ie=Afi'b{~Io,ng'ér a ‘n1ino'rlfad‘ t_6-'7sinjply‘be'” *
`‘ignored; Co’ns'ur’_ne‘rs‘5a‘re"—s —'n1ed'i"catin’g’with"‘obscu're“‘
`botanical pré’p*a;ata‘6nsqt5 such an"éxté‘n’t£th’at“th‘é=use"_ L
`
`-of - herbs
`the“ United *St“ate's‘“isJ do‘ultil"ing“eVer3i‘"foil?‘ "
`'efe'r'e'm;
`l_i‘s‘t‘fth*e‘ld‘rijgs'
`;_'*
`"
`years.
`lnclhd d'=am"orig~t
`aréély7
`‘r"eg1ilate'd'prod-*
`
`
`g
`Vgwvé dieta_ry=iten1.,
`_
`if
`’
`V
`ucts are son_1;é7genLiiin‘ely-~be
`ficial agents": "'But"also"
`§_i‘de Effé‘cts il“nVdéx"‘ pi" ‘oints the‘ ph’a‘rrn"ac’é'utbica\i‘st‘flg
`M
`lurking amdng9th_érri*aré' a'7\_Iariet’yI”of‘unté*stéd“‘nostrUfnsf
`associated wit'h*ea6h“‘ of‘l§§666*”d'istihtft“a‘dvérse7"7
`with little ma
`age
`var
`i
`i
`'
`4
`i
`'
`‘réactionrs,
`--
`-
`lrlirangleé o'f{{thera;V _}'
`l
`Iiidlcatlp
`’r>e’utic‘ orznons ff9.r an¥:rai'v;én:.diagnosi$;-‘;— r
`.r s
`. *
`V
`"
`l
`
`A 5 v_,_abr,-,,_ lT,e=atmem;
`V
`w

`s
`.:
`"
`’
`
`'me‘nt of'r,iearly'
`‘ ofoo
`
`l Which herbalssshouldrbeotakenzserirouslyrand-which.d.is—.-
`mi§.sed? luntil=_n9w;..“thete~th.ad:Abaen*no.singl.e, §_uthor,i—;.
`tative sourcee;;tQ'-ztum '90,. f9r_.‘an§We,E$,..;>-BUtt;:W|th.;‘Ih._
`advent. of PPR rforilterba/4Medi¢in~es~» Wibeeni
`
`r
`
`,.
`:..
`
`
`
`
`
`
`r
`
`"
`
`'
`
`'
`
`“
`
`'
`
`,
`
`
`
`0
`
`-
`
`O O I
`
`
`
`
`
`
`
`important newv..»smedica|:..~-r§ferenc;e:l:~incl.udes:detailed.
`informat_ion» on r each . sp.|lant?se.:physi.caI;icharactsristicetl
`chemical c9m.p9sitiQn.~.== and.<nhysi9!0gi.ca|- effects» along«:.
`.
`with 'a summaryr.oJi;its aoclcesl:-lte.de~indications.lcontraindisr;
`-v’ strgngtfisoo
`;
`cations,=drug in,teractions_, side efiects.; an_d dosage.
`_
`_
`-When apprqpriate,‘syniiot6mis;a’rpd*»tréétnfient‘bf? “7'génerica;l'|y.>
`doseare discussed-?as<we|l‘::
`’
`'
`i"
`'
`*“‘Cb"st ofi,j[he?aiwfc.‘uidéfprgin_des“_a‘qqi;ckf¢/éryiew‘cit;
`“ti-Te‘
`relat‘iVe"ex"pé_,o __}’of7‘th> , lead; pg ,tij.érfap:eu.tic:i
`Aulthotigh
`}options for a variety oflcomrnorffindications;'
`“ M
`
`Or
`'m°0it°f9€1:,
`v »in..?~ the? Um:
`’
`ai'llv‘driJgs”de‘s‘cribedl /
`Medicinesprovides]youV;the,.;cl_
`ar>r>rove.d 77|'Labé|§i’hé{—eth.]eI‘~‘.»tiiidings. ~.,<>Lf.—ii.he:I:'Germrah. FDR» ‘PPR fF°j*‘.Né"Pré5éf’P’fi9ii'"DféI3$®£ ’3fi;d'T?'PDR .F<?,f°;‘T‘
`Regulatory ."_ Au'th_o."
`’_s,.: herbal ' vlv;ltc'hqqg.ohff_agfengy,;_ _’ j Oblytlgalmoldgj/?.'f:-’\lVe’re“ce'rtain_ that hoti’ll‘_findV’“it"frnal§es_ 2 5
`COmmiSSidn-=,Efi.“‘g,-
`tiitéd.{Wi.thi_,exhéau.$fiYs?‘.|iterat0fé.r7" afezr»?PD='?D**.3t¢“d'
`.. §e!¢;"=ti<.>‘iifa?t ‘r..?a0do¢?§'€%f.th?..fi_rl
`
`
`
`ever before}
`reviews fr¢ff?~u:Il5é,‘I«;Ph5it9Ph3iiF? U-S
`!n’$titU5I-9 font .
`'
`“ l
`
`tiff
`'
`Theise-.eF9p9:,
`e.-P.'r'.e5Ae='r‘t'::§heo.~ v "rWith~ the advent,o_f th,e_;l?_DR Companion;Guide:andlPDR;, t
`
`?Ft,'a!_vsar;‘9.
`.‘?”§b;'ee a3$?5.5m‘?Fl-.»t;9f.3 -,...-.for. Herbal L1}Me.dicines‘,r. the ‘complete.rosterr-.ofrPDR’s.-
`§.afety'ahql 9ff‘3;¢tiVene$$[~¢l!T.'e“t'¥ -
`-"medical refereficesfrnow._in¢¢ldd»es:
`‘
` 'l-.
`Physicians Desk l:?éféreficé®i~
`.
`a
`i
`',
`,_
`\
`;
`_
`, __ j
`H
`_A
`
`~ PDR_Fof7Nofjbre§c,1ipti0-h Dfugsaw
`Now, when""patient_s p’eppeVr;you=_with que's?ti‘on’s{ab'out{
`’
`‘
`~
`thelatestr‘Thérbl:du'jour,""ePDR—forHerbal-Medicinés"can
`-‘PTDR For”OphthaI_r”n“oIogy@ ’
`.
`,
`_
`_
`*
`PDR Qompgnibhigg,-dérM2..
`provide you§With_‘at rational:-fbasi'siforiresporisei‘=¥lt~tel|s-~'
`
`
`,..v_~«o.-;‘PDR®for1'Herba/7Médi¢iné,§»TM~'~"~
`"p which botarjiicals-rto_*encourage—an'Ci‘whiich tdilavoid.-¥A|t
`clearly distinguishesfldetweeri‘Vali‘d indications?and5l)e=-"L ‘ - ‘PD'R® Médic”aI"Dictio"nary”V’
`0
`ciousclaims, warns of conflicting conditions and drugs,
`PDR® Nurse's ‘HandbookTM
`and provides [you with an exhaustive ‘bibliography of the
`PDR® Nurse's Dictionar)/TM
`relevant clinical literature on each medicinal plant.
`It is
`PDR® Atlas of Anatomy""
`a truly indispensable reference in an era when more _
`PDR Supplements
`
`H
`
`L:
`
`__
`T
`‘
`
`1‘ 7 ‘V
`"
`
`_
`"
`
`“-
`
`-~
`
`i
`
`a
`
`5
`
`i
`.
`
`
`v-
`
`~
`
`-
`
`.
`
`_
`i-3‘?
`-
`
`I
`
`‘
`
`T
`
`‘
`
`.
`

`
`i-
`
`E
`
`'
`
`,
`
`,
`
`.
`
`I
`
`.
`
`‘
`
`AX
`
`".
`
`_
`
`-‘-
`
`Astrazeneca Ex. 2046 p. 8
`
`

`
`
`
`_,
`
`-
`
`'-
`
`‘
`
`~V -
`v
`
`
`

`
`A_
`
`e.

`
`A
`
`1
`
`A
`
`.~
`
`.
`
`t‘éba‘e‘6f‘billi‘hg'§daes.
`tilnii‘
`‘d
`l,PCs and.PC’
`
`‘
`"l
`"
`
`
`
`
`
`
`i
`
`0
`
`V
`
`‘
`
`
`
`
`
`
`
`
`
`jg ff;
`
`ix
`
`‘ *
`'
`
`“
`
`_. 3.
`
`
`
`
`
`‘
`
`
`
`
`
`
`
`Astrazeneca Ex.
`
`2046 p. 9
`
`
` and emphasis’: as the: approved labe lngfifo the “prod?
`PDR and its majforlcompanlon vo mes arehalso found
`ucts. The Food and Drug Administration (FDA) regards
`in the PDR® Electronic LibralyTM on CD-ROM, now used
`V in Over 40.900, practi9es,,l,...:.Ihis..Wln,dows:com.i29ti.0l,ei.wordssame"in.,-.languag9».and iempbasis as reel-lair:
`
`disc provides users with a‘ comp e e"‘”database‘”of,'PDR .,,ing'.:\/:ERBAT'l‘M_‘use ,th::eT;,':é;ap‘prQl[;gqJabeljfigtprgvidjrjgi
`A
`"
`‘
`'.lnfqrmatiQn that is
`prescribing information; electronically searchable for
`,”‘s’u‘ch ‘infor_'r}jati6n;‘
`;Ful;thelgmore,g,,
`
`
`'
`€3lPi?'fJ0Yed‘,l€*.'?0
`ssbviit“e?.use{oi,txiie.
`instant retrieval; ';..i-:»A 4stan'd=ardsr>'subscriptiontti-n‘cIudes 2
`'
`"
`I’
`‘
`”
`emphasized,’,in;’the
`rogram i *—-"sets-’ih'a bo_x,,_'or_in capitals,Vboldface,;or.Vita|_ics, must be _.
`
`PDR's sophisticated»:2‘presciriptidhlscreenirig‘f
`M
`A-”gi‘yeAn“the same,,emp’h.a .__‘S“=llfl,.;,/"'DR.
`_.
`‘cal :"5st‘ructures’,?::illustr1a:-
`W
`V
`“ ‘.';Op‘[§|'on'a|‘zf-=».
`3
`A
`4
`_.
`..,.
`i
`V
`‘
`The FDA “.33 @.‘.59:l'7399gniZ9§Uh5TF H.‘-'3,-EDa34Ci»A9t.:—~d~995;
`= which
`howevenl.iilm.itie,till?f;~.man'1
`’
`
`
`
`
`iiéé?.a.ifproductih_a.Si..been.— l!\"“V':§
`may use an approved drug
`
`.e
`.
`,.
`_
`,
`’a'i?'.Pr9l/ed for;me3ti§eting,«;a;-.PI1¥.Si9iansmavi-cheese;tQ:rzre:=’
`.
`scribe it for,_._uses,.,_o_r-_i_ntreatment,;regim:en,s,,or,patient:.
`U96" —,ln-;apr>rc>‘V}edllabeline.
`iiié.puI,ati°n,sith.ét,are 0'9.
`'
`
`.a¢..c..e.pted =m‘ed,icaL»vnr;elct_l9e
`The FDA also,olt;setve2§;i
`reflyected ineapprgyed drug; _
`nciludes drug use that is not
`_
`abeling. For products that do not have official pack-
`by
`Forpe g_,
`I age circularsfthe‘publisher has‘emphaysizedithewneces-~- " -A ~ 7 ‘
`also Pockét'*PDR*9, a‘:Uhique"handhe|
`sity of describing s'uch?«pro"clu‘cts "cc'n‘lprehehsiVel|y;'“so<
`base of pres_c_ribin_g giinforihatlonltha‘
`.; that physicians ‘can'i=l<l‘avee‘»i access to all
`information
`pocket. For‘‘facillit_i£el
`‘ with "large," ‘me
`essential for intelligentland!‘info'rrhed*decisionim7aking'.“
`cmation system‘s; ‘PDR
`’
`Particularly i'n*theica‘s'e5"ofi o“ve‘rithe-counter dietaryi‘-suly‘ 3
`a preformatted‘ text file‘ ny
`mements, "it-=should ?b"e"‘—“remembered7that‘this ~iiitorrna- *r~ -A
`one who wants‘ t‘b”iunl*,ja'*fest ‘qljo,u,lo,li_ oh
`tioh has not‘-hbeénk AV/aluated"~’by9l~?the-I Food ‘and Drug
`‘osed prescripti,on,.¢thel‘e
`,
`
`
`:Administration,” and'th"at su‘c'hf'rJ'r*o‘duct’s 'a’re"not 'i'fitend- —‘ F A
`ide Effec'ts,T‘ Ihdicafltion,s,_ Qntr_al_
`d1}to*diagn"cS'e‘, treat,.’ctjr
`r‘vprevent=-any di‘se’ase.~ *‘ “ "
`.«~ sophisticated gsoftwere jc‘a’p‘
`‘lje
`,
`.
`
`9reenins1ais20*0.riu§8.
`.
`\ nif
`functionwef,
`publishersislthe/,compilati,on, o_:rga:ni-H A
`
`rig alternatil/e‘s'fo'r's‘any pro ’e‘mat' medlcatlor‘l.”'”
`._zation, and distributionof this information.«»;;Each prod.
`A
`pore information on these or,, any_.o_the member ‘
`uct description has been pljeparediby the manufacturer, g
`
`the growinggfa_rnily of l?DR",prod_ucfts' “
`,e‘ call,
`
`- »;;a,nd editediia “dapprovedpby the ’manufacture‘l”s medical" :-
`
`»free,1-80(5¥232-737,9Cjrf§:lX;2Q1§5Z$:
`-
`A
`d{4=l9artmen*t§,’-=ihetlic‘ail director,’' and/or‘gmediéal iconsul-V 1'
`.
`Physicians .'..p.esk ..Referen._ce
`plibiI,i._s.hed_.,.-by,.Mecli<;al~
`ln org€aniiing>island"i
`lo"res'enting’j"1thefmaterial, in
`’
`'Economic..S'fCo
`.¢_o_¢p;eie,
`particip”a_ting:7~ 7..,a"t-.
`“
`,’_Phys;icians"*"»Desk'Reference,‘-the'*publis’her”does‘not "-
`
`
`.m'anufactulie.;rs
`‘act:fsuiI-I,,"i'iigth'_-entry pr.
`,
`.. if-
`"w rrant or 'guarahtee~'éln‘y"df the pro“du'cts‘described,, or"
`
`_an- exactcoplr; 9fs':th9;i i>i9dUc,fEré,.iFDél:ai2i2. V.e«d.,-.|.ab9[!i‘h.g: i
`_pe_rio_rm any *i’ndep_en‘dentfanélysls -in coinneotionl with“ l _
` .,
`_,
`
`‘Under the federal Food, Drug’ and Cosmetics (FD'&C),s,
`any‘ ' of. the f’ product info‘rm“ati'on f'co"ntained ‘ herein.‘
`l-fPhysicians“fDe-;§'k"ARefereflcé,'doés”hot
`,as”s’urn'e,’'ahd’A *1
`"V
`Act, a drug approved for marketing may be labeled, pro-
`
`,~moted, _and?~i"eldiiertis;ed»"by"the??manufactu"rer~for7*'ofilyl~f
`4,
`y
`.
`_
`_
`.
`,,
`
`those usefs“-foriwhich?it'he-drii’g'—s«’sefetyi7and*efieetive
`"e‘xlore"ss|y ‘dis‘C|éimlS".‘ "any ‘obligation’ to,‘ 0|'0tairi;and‘
`
`*-*include any inioimetion ‘o'the—rtha’n that providedjto‘ it‘j_l_oy»_
`I j A‘
`
`. ness have been established; 7"Th'e‘”’Code""ofi"Federa ‘
`the manufacturer.
`It shouldbe understood that‘ bymak-'
`Regulations 201.100(d)(1) pertailniflg.,.t9.l.-:,|abeling.,for-
`_
`prescription‘ products require$«'i$h'?t. for.
`[ing this majte.ria|,,,availab|el, ,the.. p,ut;|is_he_t.;,i$ :nOt._ad\l_0:,—».»
`
`.~__cat'_ing the,us_e;.of anylyproductsdescribed her.ein,_ _.nor__i-si , ;
`H
`M
`H I
`“indications, effects, dosages, routes,
`,.the publisher-respqnsibletvfor-misuseeotaslorodluct,due. :«,
`A-an,d‘.f'éinAwl'.eie%lI, ;»
`-
`frequency and duration of administration
`a. to. .typographical,,~error..» Additional
`information.._on.,_;any - ,,
`vant warnings, hazards,
`contraindication§A,:__s._s,ide.
`.=_=product“may,_be—obtained,from the.manuf,acturer.
`A
`effects. and precautions” must be =“sar,ne~.—in,,.language_:
`
`
`
`enihancementse,, irl,c_|,u,d.‘
`y Merck MarVjl,til',L.‘:2,_.I’f¢':i“r_';1'd ,3
`well as a 'cor'np're'-hen _
`
`
`
`

`
`
`
`CONTENTS f
`
`
`
`
`
`at
`
`_'
`
`I 1
`
`-Manusfa turers’ IIIdeX.‘(White Pages)
`I Section 1 on
`Lists all pharmaceutical manufacturers participating in PHYSICIANS’ DESK REFERENCE.
`Includes addresses, phone numbers, and emergency contacts. Shows each manufacturer's
`
`products and the page number of those described in PDR_. ’
`
`i
`
`to
`
`,
`
`"
`
`‘
`
`_
`
`Brand and Generic Name Index (Pink,Page,s),
`,
`s
`__
`V" 101
`
`Section'o2l
`I‘
`o
`I
`a
`V.
`.
`.
`V Gives the page number of each product by brand and generic name.
`
`V
`
`
`
`Productcategory In_de_x, (B|ue'.Pages)
`'
`M
`M
`Section 3
`'
`'
`‘
`o
`Lists all fully described products by prescribing category. An overview of the. headings I
`
`
`
`
`
`
`
`
`V k , s ‘_lappears on pages 201 and 202. .
`
`.
`
`I
`
`K "
`
`'
`
`V
`
`o
`
`.
`
`.
`
`s
`
`.
`
`4‘
`
`T 201 g
`
`I
`
`Product lclentification Guide (Gray Pages) .301 V i I ,
`
`Section 4 V I
`-
`I
`.
`_
`_
`Presents fullcolor, vactua/-size photos of tablets and capsules, plus‘ pictures of ‘a_ variety of other
`
`Idosageforms and packages. Arranged alphabetically by manufacturer. I
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Product Information (White Pages) . — . ’ ’ ’ . . ‘ . , - ‘ ’ E ‘401 ’
`
`
`
`
`- Section
`The main section of thebook. Includes entries‘ for over 2,200 pharmaceuticals. Listings are
`
`
`
`
`
`« ' I'arranged alphabetically by manufacturer. ‘
`
`
`
`
`
`
`
`
`
`
`
`V
`
`s
`‘V
`
`.
`
`o
`
`I
`
`,
`
`-
`
`'
`
`'
`
`_
`
`I
`
`_
`

`
`.
`
` . Diagnostic ‘Product Information 3467
`
`..section6
`to
`to
`_
`I
`to
`I
`V
`,
`_
`.
`I
`_
`A
`'
`_ Gives usage guidelines for a varietyof common diagnostic agents. Arranged ‘alphabetically by manufacturer."
`
`..... .. ..............................
`...................
`.....
`I‘)"rugV-Infornjation Centers ........... .. .....
`A ‘national directory of institutions that answer. queries regarding drugs. Arranged alphabetically by state and city.
`. Key to Controlledssubstances categories-..v._..’. ......... .._. .....
`..... ..-‘....
`........
`......

`.
`_ Gives the definition of each category and the prescribing limitations that apply.
`'_
`Keyhto FDA Use-in-Pregnancy Ratings....
`........................
`..... .; ..... ..' ........ .. .........
`‘ Provides the exact interpretation of eachrisk/benefit rating. ‘
`'
`........
`M U.S. Foodand Drug-AdministrationTelephone Directory....'........'........r....
`‘
`_
`Gives numbers of key reporting programs. and information services.
`a
`.
`v
`‘
`‘ _
`Poison control centers'.‘.....' ...................
`.......... .._. ..........
`...... .. ....
`........
`A national directory arranged alphabetically by state and city.
`'
`
`“
`
`M
`
`“
`
`.
`
`'
`
`.
`
`.
`
`-
`
`.....
`
`....
`"
`
`V
`
`.
`.
`.... ....347
`" :


`........................ ..‘...348’
`.
`A
`'
`,
`M
`..........
`.....
`.... ..34'78
`.
`*
`I
`
`.... ..22O
`'
`
`'
`
`_
`
`Astrazeneca Ex. 2046 p. 10
`
`

`
`PRODU.'CT‘~:INFORMAT|ONif?"
`
`'
`
`‘N OVARTISKPHARMACE UTICALSH/202,5
`
`A stifl‘ protective liner covers the adhesive side of" the .
`system — the side that will be placed against your skin. This ;
`liner must be removed beforeapplying the system. Slide the ‘
`protective liner sideways between your thumb and index
`finger. Then hold the system‘at one edge. Remove the
`protective liner anddiscard it. Try to avoid touching the
`adhesive.
`.
`-
`
`I
`
`Apply 'the‘ddhesive side ofthe system tolalcleian; d.ry_are'a of
`the skin on the trunk of the body (including the buttocks '
`and abdomen).
`.'
`V
`=
`,1
`

`V
`:
`‘
`HOW‘SUP.PLIEDf:.
`Estraderrn ‘estrqgiiol transiiermdl system 0.-05_mg/ day —-
`each 10 cm2 systembontains 4 mg of estradiol USP for nom"-
`ina1* delive"r‘y"of 0’.05'ing of estradiol-per day.‘*’
`E '
`"
`_'
`I
`Patient Calendar Pack
`'
`"
`'
`‘
`'
`‘
`of 8 Systems .................................
`NDC0083-2310-‘O8
`Carton of 6 Patient Calendar Packs‘
`"
`‘
`'
`' "
`*
`
`of 8 Systems‘
`Nnc 0083'-2310-62
`Cai‘ton_of‘I Pa en
`.
`,
`
`of'24 Systeins ..‘
`.. NDC’008.3-2310-2'4 .
`Estrade’rn‘i‘est-radial transdermal sys m"_0.1 mglday —'each '
`
`20-"c‘n'12'systern' contains 8'mg of estradiol USP’fo'r non'rinal*
`delivery‘of 0.1 mg of estradiol perday: ‘'
`-
`‘
`’
`Patient Calendar Pack
`'
`
`of8~Systems';.‘....
`V’
`" "
`boss-2320-ops 1
`Carton of 6 Patient
`
`NDG"0_0§3-2320-V6.2
`
`
`6f_‘24"Systems .." A
`N1_)“ciqos3.232o—24
`
`
`*5: DESCRIPTION .
`
`
`.
`Donnot store ‘above '\86°l"‘ (30°C).
`Do not store unpouched. Apply immediately
`from the protective pouch.
`~
`.
`‘
`i y
`
`
`
`
`“
`
`
`
`‘
`
`e
`‘
`
`1. ESTROGENS INCREASE THE RISK 0.F:CANCER, :OFf‘
`
`.='—TH.E,.U.TER.US IN-‘WOMEN WHO. HAVE-HAD THEIR ‘
`'1, 1
`’IA'
`_-MENOPI_\U.SE.-,(”CHANGE _O,F_;LIF,Ej',).
`:
`.
`.-1;
`If you use. estrogen-containing; drug,
`is important .
`, p_;,vjsi_t your:__:_doctor~regularly— andir.-‘eport any nnusual
`..
`" vaginal bleeding right away. Vaginal bleedinggafterv
`’_ menopause may-:be:a warning-.sign:of.-zuterine cancer. J
`Your doctor should‘evaluate=any-unusual~vaginal1bleed- I
`ing to find out thecause.
`-»
`-
`-.
`.
`,
`’-r2. -.ESTBOGENS—..SHOULD NO'.IT,.BE’
`ED. DURING
`~xPREGNANQY-- _
`'
`1'-_
`r-_ {.12 I
`2.;
`.'
`,_
`,. :iEs,trogens' do ;not p'r,event..miscarr1a-ge (spontaneous »
`. abortion).-and are not needed inthe _d'ays—fo1lowing child-. ~;
`..birth.- If-youa..vt_a_ke» estrogensgduring, pregnancy, your
`1 unborn child rhas.,=a vgreater than-' usual "chance. of f;_
`having bflirth,-_cIefeots. The. risk of developing these de-,:
`’f,e5:tS:iS small,<-but-clearly larger than the risk inchildren ’ ;
`whosezmothersadid not-Jtake estrogens-during.pregnancy. v ,
`3 Thes

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