`
`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