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INDEX
Vol. 7, Nos. 1-43 pp. 1-1268
Jan. 2-Oct. 30 , 2009

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

    ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)
      – Bioequivalence
        – – Data submission, FDA issues draft guidance, 471
        – – Product specific studies, FDA issues final recommendations, 685
        – – Studies, FDA issues rule, 98
      – Clobel patent infringement alleged (N.D. Tex.), 63
      – Generic drugs
        – – Allegra-D maker tries to block generic (D.N.J.), 119
        – – Avinza, infringement alleged over generic ANDA (D.N.J.), 1071
        – – Backlog addressed by FDA, 1257
        – – Blood pressure drugs, ANDAs infringe patent (D.N.J.), 938; appeal filed, 991
        – – Cardene, generic ANDA challenged (D.N.J.), 401
        – – Doryx generic ANDAs challenged as infringement, 14
        – – Fortamet, generic ANDA challenged (D. Del.), 97
        – – Truvada V drug ANDA infringes patent (S.D.N.Y.), 10
      – Lotrel low-dose ANDA challenged as infringement (D.N.J.), 13; dismissed, 201
      – Pataday
      – Withdrawals not due to safety or effectiveness, FDA says, 19; 19 drugs withdrawn, 715
    ACCREDITATION AND CERTIFICATION
      – Pfizer study subject protection program accredited, 417
    ACCUTANE
      – Acne drug blamed for inflammatory bowel disease, new trial ordered (N.J. Super. Ct.), 313
      – Discontinued due to generic competition, 780
      – Expert witness excluded (M.D. Fla.), 1039
      – Failure-to-warn of suicide risk, maker wins summary judgment (11th Cir.), 705
      – Inflammatory bowel disease blamed on drug, jury verdict for plaintiff thrown out (Fla. Dist. Ct. App.), 1252
    ACETAMINOPHEN
      – Prescription drugs, FDA panel urges ban, 802
    ACTIMMUNE
      – Class action over off-label use marketing dismissed (N.D. Cal.), 583
      – Indictment of CEO over off-label use promotion upheld (N.D. Cal.), 675
    ACTONEL
      – Bone-blocking drug, generic version challenged (D. Del.), 150
      – Osteoporosis drug patent upheld against generic maker (Fed. Cir.), 581
    ACTOS
      – Diabetes drug patent dispute, attorneys' fees upheld (U.S., rev den), 1166
    ACULAR
      – Eye inflammation treatment patent upheld (U.S., rev den), 117
    ACZONE
      – Acne drug ad overstates efficacy, FDA says, 1001
    ADDERALL XR
      – Amphetamine capsules, generic maker to get license (D. Colo.), 1195
    ADVERSE EFFECTS
      See also SAFETY
      – Mixing prescription and OTC drugs, adverse reactions in seniors possible, 21
    ADVERSE EVENTS
      See also SAFETY
      – Canada, reporting changes considered, 721
      – Genetic basis for certain events, FDA releases data, 182
      – List of drugs posted by FDA, 1202
      – N.H. reporting bill signed, 921
      – Ore. reporting system, few pharmacies participating, 950
      – Orlistat and liver injury, FDA reviews, 1002
      – Raptiva, FDA issues advisory, 233
      – Toll-free number on medication guides, FDA issues guidance, 686
    ADVERTISING
      – Aczone ad overstates efficacy, FDA says, 1001
      – Avodart, FDA says TV ad is misleading, 271
      – Brazil revises rules, 27
      – Compliance plans urged, 1110
      – Depakote, FDA tells maker to pull misleading materials, 159
      – Efficacy and risk data, FTC seeks comments, 776
      – Ertaczo ad inaccuracies, FDA warns maker, 1051
      – GSK plans $400M charge, federal probe cited, 160
      – HRT claims, jurisdiction lacking over ad firms with insufficient W.Va. contacts (E.D. Ark.), 367
      – Humira ad broadens approved indication and minimizes risks, FDA says, 21
      – Nalfon, FDA warns direct mailer on false or misleading advertising, 1050
      – Nexium, false advertising class action remanded (3rd Cir.), 587
      – Promotional materials, FDA pushes accuracy and balance, 1107
      – Protonix, generic advertising challenged (E.D. Mich.), 554
      – Risk information
        – – Draft guidance issued by FDA, 618; stakeholders seek revisions, 999
        – – Lacking from many Internet ads, 413
      – Ultram ER web video called misleading by FDA, 623
      – Velcade maker accused of overstating efficacy, 746
      – Yaz
    AFINITOR
      – Approved for kidney cancer, 383
    AIDS AND HIV
      – Combination drug, In Brief, 871
      – IDX889 licensing, In Brief, 191
      – Intelence labels revised due to skin reactions, 1051
      – IQP-0410, In Brief, 49
      – Kaletra
      – Patent infringement, Stanford lacks standing to make claim (Fed. Cir.), 1167
      – Pricing
        – – Isentress price cut sought, 892
        – – Norvir price settlement approved (N.D. Cal.), 942
      – Selzentry, FDA panel recommends approval, 1206
      – Specialist firm planned, In Brief, 486
    ALABAMA
      – E-prescribing system announced for Medicaid, 648
      – Generic drugs, Atty. Gen. seeks to dismiss suits against pharmacies for deceptive trade practices, 1204
      – Medicaid pricing
        – – 5 firms settle with state (Ala. Cir. Ct.), 40; jury awards $78.4M (Ala. Cir. Ct.), 227; more firms settle (Ala. Cir. Ct.), 610
        – – Verdicts reversed (Ala.), 1222
    ALDARA
      – Skin cancer cream blamed for severe symptoms, claim time-barred (D. Utah), 257
    ALIMTA
      – Approved for lung cancer, 809
    ALLEGRA
      – Allergy drug maker tries to block generic (D.N.J.), 119
      – Infringement alleged over generic (D.N.J.), 1100
    ALPHAGAN
      – Glaucoma drug, generic infringes patent (D. Del.), 1248
    AMRIX
      – Muscle relaxant infringement claim split from antitrust and patent misuse claims (D. Del.), 1192
    ANALYSIS & PERSPECTIVE
      – Calibrating proper dosage for treating certain diseases, method is patentable, 1209
      – Conflicts of interest, lobbying and gift limits, 1180
      – De-identified health information and state regulation, 422
      – Enforcement focused on drug patent settlements, 1006
      – Exclusivity rule, 979
      – Federal preemption in drug and device suits, 106
      – Foreign Corrupt Practices Act compliance, 215
      – Fraud on agency claims, 1086
      – Norvir monopoly ruling, 1011
      – Patents
        – – Reversing patent settlements, 749
        – – Risk evaluation and mitigation strategy patents, 28
      – Phenergan failure to warn claim, 353; effect on preemption defense, 658
      – Promethanzaine hydrochloride injection gets boxed warning, 1077
      – Trademarks, proving use, 52
    ANDAs
    ANDROGEL
      – Class actions seek to recoup charges paid due to collusion between brand name and generic firms (C.D. Cal.), 174; transferred to Ga. federal court, 435; N.J. suits transferred (D.N.J.), 670
      – Testosterone replacement drug, FTC accuses generic and brand name makers colluding to delay (C.D. Cal.), 145
    ANTARA
      – Cholesterol drug, Lupin gets marketing rights (D. Md.), 1194
    ANTI-KICKBACK LAWS
      – UN Oil for Food Program, Danish firm settles charges (D.D.C.), 558
    ANTIBIOTICS
      – Cephem compound double patent challenge, summary judgment vacated (Fed. Cir.), 433
      – Doryx
      – Flucloxacillin associated with liver damage, 652
      – HGS and Morphotek, In Brief, 386
      – Leaquin blamed for tendon rupture (D. Minn.), 1170
      – Plectasin NZ2114, In Brief, 25
      – R&D
        – – Biogen and Aveo, In Brief, 386
        – – Paratek and Novartis, In Brief, 1208
      – Restanza, In Brief, 1084
      – Trovan maker accused of violating international norms (2nd Cir.), 147
    ANTIDEPRESSANTS
      – Celexa competing patents, two claims invalidated by prior art (S.D.N.Y.), 673; jury awards royalty, 1247
      – Consolidation of product liability claims denied (D. Mo.), 639
      – Effexor
      – Failure-to-warn of suicide risk, preemption ruling remanded (U.S.), 280; vacated and remanded (3rd Cir.), 497; briefs filed, 498
      – Labopharm, In Brief, 871
      – Lexapro
      – Paxil
      – Wellbutrin
    ANTITRUST
      – Amrix infringement claim split from antitrust and patent misuse claims (D. Del.), 1192
      – AndroGel, class actions seek to recoup charges paid due to collusion between brand name and generic firms (C.D. Cal.), 174; transferred to Ga. federal court, 435; N.J. suits transferred (D.N.J.), 670
      – Apotex counterclaims against Daiichi dismissed (D.N.J.), 636
      – Arava generic, jury verdict against maker upheld (S.D.N.Y.), 1023
      – BMS to settle with states over court order violations, 12
      – Cipro
      – Community Medical suit against drug maker over price may proceed (D. Minn.), 1218
      – CVS Caremark merger, FTC probe sought, 565; pharmacists group alleges monopoly, 565
      – EU, drug firm seeks exemption, 1179
      – False statements, former exec ordered to write book about case (D.D.C.), 679
      – Hytrin monopoly claim remanded (9th Cir.), 91
      – K-Dur purchasers class certified (D.N.J.), 38; special master recommends dropping, 175
      – Leibowitz as FTC chair, more scrutiny predicted for drug industry, 261
      – McKesson settles price inflation claims (D. Mass.), 909
      – Mergers
      – Neurotonin, monopoly claim against maker may proceed (D.N.J.), 1026
      – Nifedipine direct purchasers class action certified (D.C. Cir.), 229
      – Norvir maker cleared of monopoly charges (9th Cir.), 791; rehearing denied, 987; Analysis & Perspective, 1011
      – Ovcon settlement reached (D.D.C.), 12
      – Plavix suit, former executive pleads guilty to false statements (D.D.C.), 401
      – Reverse payment deals
        – – Position of Obama administration sought, 476
        – – Targeted by FTC, 372
      – RxUSA monopoly claim rejected (E.D.N.Y.), 1132
      – Singulair class action voluntarily dismissed (D.N.J.), 1099
      – Tranferorer judge's ruling cannot be vacated (3rd Cir.), 1134
      – Transparency
        – – Pushed at Senate panel, 862
      – Tricor, consumer suit over generic delay, settlement approved (D. Del.), 500
      – Unenforceable patents, direct buyer plaintiffs have standing (2nd Cir.), 1217
      – Unlawful conspiracy claims, tranferorer judge's ruling cannot be vacated (3rd Cir.), 1134
      – Videotaping testimony by FTC permitted (D.C. Cir.), 1253
      – Wellbutrin, direct purchaser antitrust suit may proceed (E.D. Pa.), 308
    APPLICATIONS
      – Acetavance, In Brief, 596
      – Acurox, In Brief, 51; expedited review, In Brief, 272; preliminary review letter, In Brief, 747; review continues, 811
      – Afresa, In Brief, 324; new application, In Brief, 595
      – Alogliptin and Actos combo, In Brief, 1053
      – AM461, In Brief, 978
      – ANDAs
      – AR-12, In Brief, 570
      – AR-42, In Brief, 324
      – Aricept, new drug application planned, 808
      – Arzerra, In Brief, 164; called safe and effective by FDA panel, 649; review extended, In Brief, 720
      – Aspirin-ulcer drug combo, In Brief, 541
      – Asthma drug combo, In Brief, 896
      – Avodart, In Brief, 1178
      – Bepreve, In Brief, 105
      – Botox, In Brief, 626
      – Carisbamate, In Brief, 1005
      – Cefazolin, In Brief, 655
      – Ceftobiprole, In Brief, 1055
      – Certriad, In Brief, 692
      – Cervarix
      – Ciltryi, In Brief, 1117
      – Cimzia, FDA wants more data, 46
      – Cinryze
      – Cladrinbine, In Brief, 1149
      – Clolar, more data sought, 1176
      – Colitis drug, FDA wants more data, 46
      – CorVue, FDA panel says data insufficient, 892
      – CorVue, In Brief, 1237
      – Cymbalta, In Brief, 655
      – Dantrium IV, In Brief, 1149
      – Daxas, In Brief, 871
      – Denosumab, In Brief, 24
      – Diabetes drug combo, In Brief, 896
      – Diabetes treatment, FDA to apply guidance, 295
      – Durezol, In Brief, 324
      – DX-88, In Brief, 385
      – EOquin, In Brief, 872
      – Erbitux, In Brief, 134
      – Exenatide, In Brief, 541; 811
      – Fampridine-SR, In Brief, 385; 571
      – Fenretinide, In Brief, 450
      – Flutiform
      – Fortesta, In Brief, 1237
      – Fusilev, In Brief, 1208
      – Ganciclovir ophthalmic gel, In Brief, 134
      – Genasense, In Brief, 297
      – GGTI-2418, In Brief, 192; 271
      – Imitrex, In Brief, 213
      – Intelence, In Brief, 192
      – Intermezzo, FDA wants more data, 1263
      – Intermezzo, In Brief, 719
      – Intuniv, In Brief, 895
      – Invega, In Brief, 191
      – Isolagen Therapy, In Brief, 298
      – Krystexxa, In Brief, 1084
      – LiquiXR, In Brief, 570
      – Loramyc, In Brief, 720
      – Lucassin, In Brief, 719
      – Lumizyme, FDA seeks more information, 270
      – MGX006, In Brief, 838
      – Micardis, In Brief, 1237
      – Miconazole Lauriad, In Brief, 977
      – MonoSol XR, In Brief, 451
      – Nebido, In Brief, 1054
      – Nexium, In Brief, 25
      – NGX-4019, In Brief, 25
      – Nonsteroidal anti-inflammatory drug, 418
      – Nuvigil, In Brief, 1150
      – Ondansetron ODFS, In Brief, 691
      – Onglyza timeline extended, 513
      – OnoGenex, In Brief, 1178
      – Onrigin, In Brief, 212; application accepted, 486
      – Pegloticase, In Brief, 51
      – PEGylated interferon beta-1a, In Brief, 838
      – Pennsaid, In Brief, 926
      – Perceiva, In Brief, 1237
      – Pixantrone, In Brief, 134; rolling submission, In Brief, 451; priority review sought, In Brief, 747; NDA accepted, In Brief, 1005; action date, In Brief, 1053
      – PN 400, In Brief, 596
      – PolyHeme not approved, In Brief, 542
      – Prevnar 13, In Brief, 952
      – prGCD, In Brief, 1004
      – Prolia, In Brief, 1237
      – Provenge application planned, 1147
      – QAB149, In Brief, 1237
      – Qutenza, In Brief, 953
      – Reloxin, In Brief, 78
      – Remoxy, In Brief, 811
      – Replagal maker plans license application, 1236
      – Restanza called safe, but not effective by FDA panel, 649
      – Retigabine, In Brief, 1116
      – Rexin-G, In Brief, 720
      – Rezonic, In Brief, 747; 1150
      – Risperdal, In Brief, 213
      – Rituxan, In Brief, 595
      – ROX-888, In Brief, 192
      – Saphris, In Brief, 105; 238; 927
      – Seroquel XR, In Brief, 24
      – Stelara, In Brief, 626
      – Sunitinib, In Brief, 595
      – Surfaxin, FDA wants more data, 477
      – Surfaxin, In Brief, 1085
      – Symbicort, In Brief, 418
      – Tarceva, In Brief, 352
      – Trelstar, In Brief, 838
      – Twynsta, In Brief, 1237
      – Tykerb, In Brief, 384
      – Tyvaso, In Brief, 324; 515
      – Ustekinumab, In Brief, 25
      – Velaglucerase alfa, In Brief, 811
      – Vimovo, In Brief, 812; 1055
      – Xarelto makers plan to respond to FDA, 866
      – Xiaflex, In Brief, 515
      – XP12B, In Brief, 419
      – Zegerid, In Brief, 164
      – Zenpep, In Brief, 747
      – Zevalin, In Brief, 811
      – Zogenix, In Brief, 212
      – Zyprexa, In Brief, 78
    APPROVALS
      – ACTOplus met, In Brief, 569
      – Acuvail, In Brief, 896
      – Adcira, In Brief, 626
      – Alimta approved for lung cancer, 809
      – Apidra SoloSTAR, In Brief, 272
      – Arzerra approved, 1262
      – Astepro, In Brief, 1054
      – Atryn approved by FDA, 190
      – Avastin
      – Average approval time down at FDA, development time up, 74
      – Axert, In Brief, 692
      – Azor, In Brief, 570
      – Bepreve
      – Berinert approved, 1207
      – Besivance approved, 651
      – Cervarix cleared by FDA panel, 1234
      – Cimzia, In Brief, 596
      – CIP-Tramadol ER, In Brief, 212
      – Citizen petitions, FDA issues draft guide, 122
      – Coartem tablets approved for malaria infections, 416
      – Colcrya approved, 923
      – Creon, In Brief, 541
      – DaTSCAN, FDA panel recommends approval, 951
      – Degarelix approved, 22
      – DX-88, FDA panel favors approval, 188
      – Effient approved, 836
      – Elitek, In Brief, 1238
      – Embeda, In Brief, 978
      – Extavia, In Brief, 978
      – Fampridine cleared by FDA panel, 1235
      – Fanapt approved for adult schizophrenia with warning, 539
      – Feraheme, In Brief, 812
      – Folotyn, approved for lymphoma, 1146
      – Forteo, In Brief, 896
      – Gelnique, In Brief, 134
      – Generics
      – Gleevec approved, 23
      – Helixate FS, 978
      – Heparin, In Brief, 1055
      – Hiberix gets accelerated approval, 1002
      – Ibuprofen Injectable dosage approved by FDA, 717
      – Ilaris, In Brief, 748
      – Invega Sustenna, In Brief, 927
      – Kapidex, In Brief, 164
      – Kogenate FS, In Brief, 953
      – Krystexxa, In Brief, 719; 927
      – Labopharm, In Brief, 871
      – Lamictal XR, In Brief, 656
      – Lexapro approved for adolescents, 350
      – Livalo approved, 923
      – Metozolv ODT, In Brief, 1085
      – Mirena approved by FDA, 1177
      – Multaq
      – Nexterone, In Brief, 50
      – Onglyza approved, 922
      – Onglyza, FDA panel favors approval, 414
      – Pegintron cleared by FDA panel, 1176
      – Prasugrel, FDA panel favors approval, 159; consumer group opposes, 649
      – Prolastin, In Brief, 1237
      – Prolia approval recommended by FDA panel, 808
      – Provenge, politically-motivated delay in approval alleged, dismissal affirmed (U.S., rev den), 61
      – Reclast, In Brief, 656
      – RiaSTAP approved for bleeding in patients with congenital fibrinogen deficiency, 102
      – Rituxan, In Brief, 1237
      – Rivaroxaban gets favorable review from FDA panel, 351; gets complete response letter, 650
      – Robinul, In Brief, 1005
      – Romidepsin approval urged by FDA panel, 1050
      – Romidepsin, FDA panel favors approval, 1050
      – Ryzolt, In Brief, 51
      – Sabril cleared by FDA panel, 73; approved for adult seizures, 1003
      – Samsca, In Brief, 627
      – Sanvar, In Brief, 627
      – Saphris, In Brief, 978
      – Savella, In Brief, 105
      – Selzentry, FDA panel recommends approval, 1206
      – Silenor application rejected by FDA, 446
      – Simponi for arthritis, 513
      – Stelara approved, 1146
      – Surfaxom, In Brief, 812
      – Symbicort, In Brief, 272
      – Symbyax, In Brief, 352
      – Tekturna HCT, In Brief, 871
      – Topamax, In Brief, 1238
      – Tygacil, In Brief, 352
      – Tyvaso approved, 923
      – Uloric, In Brief, 212
      – Valturna, In Brief, 1117
      – Vancomycin, In Brief, 570
      – Vectical, In Brief, 163
      – Votrient cleared by FDA panel, 1176; approved, 1235
      – Welchol, In Brief, 1208
      – Xiaflex, FDA panel urges approval, 1113
      – Zenpep approved by FDA, 1052
      – Zingo, In Brief, 77
      – Zipsor, In Brief, 748
      – Zirgan, In Brief, 1084
      – Zolpimist, In Brief, 24
      – Zyprexa, In Brief, 352
    ARANESP
      – Anemia drug illegal marketing alleged (D. Mass.), 255
      – Off-label promotion
        – – Class action dismissed (C.D. Cal.), 730
        – – RICO does not apply (C.D. Cal.), 37
    ARAVA
      – Arthritis drug antitrust suit, jury verdict against maker upheld (S.D.N.Y.), 1023
    ARBITRATION
      – Remicide distribution agreement, arbitration sought, 622
    AREDIA
      – Biophosphonates blamed for osteoporosis, summary judgment denied (M.D. Tenn.), 995
    ARICEPT
      – Alzheimer's drug infringement alleged, inequitable conduct defense permitted (D.N.J.), 796
      – New drug application planned, 808
    ARZERRA
      – Leukemia drug, In Brief, 164; called safe and effective by FDA panel, 649; approved, 1262
    ATRYN
      – Anticoagulant approved by FDA, 190
    ATTORNEYS
      – Falsified drug paperwork (D.N.H.), In Brief, 617
      – Fen-phen settlement, attorneys convicted of bilking plaintiffs (E.D. Ky.), 467
    ATTORNEYS' FEES
      – Actos patent dispute, attorneys' fees upheld (U.S., rev den), 1166
      – Fen-phen, fee award for attorneys affirmed (3rd Cir.), 1226
    AVANDIA
      – Diabetes drug product liability, sales rep properly joined (E.D. Pa.), 826
      – Failure-to-warn suits remanded (E.D. Pa.), 284
      – Investors' security fraud suit dismissed (S.D.N.Y.), 992
      – Public Citizen wants ban, 866
    AVASTIN
      – Brain cancer treatment, FDA panel favors approval, 381; approved, 540
      – CalPERS approves for ovarian cancer, 296
      – Kidney cancer, In Brief, 927
    AVINZA
      – Pain drug, infringement alleged over generic ANDA (D.N.J.), 1071
    AVODART
      – Prostate treatment, FDA says TV ad is misleading, 271
    AZOPT
      – Eye drug maker alleges infringement (E.D. Tex.), 119
    AZOR
      – Blood pressure drug, generic ANDAs infringe patent (D.N.J.), 938; appeal filed, 991

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