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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– – Data submission, FDA issues draft guidance, 471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 – 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 – Pataday
See PATADAY
– Pfizer study subject protection program accredited, 417
– 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
– Prescription drugs, FDA panel urges ban, 802
– 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
– Bone-blocking drug, generic version challenged (D. Del.), 150
– Osteoporosis drug patent upheld against generic maker (Fed. Cir.), 581
– Diabetes drug patent dispute, attorneys' fees upheld (U.S., rev den), 1166
– Eye inflammation treatment patent upheld (U.S., rev den), 117
– Acne drug ad overstates efficacy, FDA says, 1001
– Amphetamine capsules, generic maker to get license (D. Colo.), 1195
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
– 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 – Velcade maker accused of overstating efficacy, 746 – Yaz
See YAZ
– Approved for kidney cancer, 383
– Combination drug, In Brief, 871
– IDX889 licensing, In Brief, 191 – Intelence labels revised due to skin reactions, 1051 – IQP-0410, In Brief, 49 – Kaletra
See KALETRA
– Pricing
– – Isentress price cut sought, 892
– – Norvir price settlement approved (N.D. Cal.), 942 – Specialist firm planned, In Brief, 486
– 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
– Skin cancer cream blamed for severe symptoms, claim time-barred (D. Utah), 257
– Approved for lung cancer, 809
– Allergy drug maker tries to block generic (D.N.J.), 119
– Infringement alleged over generic (D.N.J.), 1100
– Glaucoma drug, generic infringes patent (D. Del.), 1248
– Muscle relaxant infringement claim split from antitrust and patent misuse claims (D. Del.), 1192
– 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 – Promethanzaine hydrochloride injection gets boxed warning, 1077 – Trademarks, proving use, 52
– 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
– Cholesterol drug, Lupin gets marketing rights (D. Md.), 1194
– UN Oil for Food Program, Danish firm settles charges (D.D.C.), 558
– Cephem compound double patent challenge, summary judgment vacated (Fed. Cir.), 433
– Doryx
See DORYX
– 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 – Trovan maker accused of violating international norms (2nd Cir.), 147
– 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
See EFFEXOR
– Labopharm, In Brief, 871 – Lexapro
See LEXAPRO
See PAXIL
See WELLBUTRIN
– 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
See CIPRO
– 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 – 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 – 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
– 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
– 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-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
See CERVARIX
– Cimzia, FDA wants more data, 46 – Cinryze
See CINRYZE
– 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
See FLUTIFORM
– 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
– 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
See AVASTIN
– Axert, In Brief, 692 – Azor, In Brief, 570 – Bepreve
See BEPREVE
– 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
See GENERIC DRUGS
– 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
See MULTAQ
– 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
– 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
– Arthritis drug antitrust suit, jury verdict against maker upheld (S.D.N.Y.), 1023
– Remicide distribution agreement, arbitration sought, 622
– Biophosphonates blamed for osteoporosis, summary judgment denied (M.D. Tenn.), 995
– Alzheimer's drug infringement alleged, inequitable conduct defense permitted (D.N.J.), 796
– New drug application planned, 808
– Leukemia drug, In Brief, 164; called safe and effective by FDA panel, 649; approved, 1262
– Anticoagulant approved by FDA, 190
– Falsified drug paperwork (D.N.H.), In Brief, 617
– Fen-phen settlement, attorneys convicted of bilking plaintiffs (E.D. Ky.), 467
– Actos patent dispute, attorneys' fees upheld (U.S., rev den), 1166
– Fen-phen, fee award for attorneys affirmed (3rd Cir.), 1226
– 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
– Brain cancer treatment, FDA panel favors approval, 381; approved, 540
– CalPERS approves for ovarian cancer, 296 – Kidney cancer, In Brief, 927
– Pain drug, infringement alleged over generic ANDA (D.N.J.), 1071
– Prostate treatment, FDA says TV ad is misleading, 271
– Eye drug maker alleges infringement (E.D. Tex.), 119
– Blood pressure drug, generic ANDAs infringe patent (D.N.J.), 938; appeal filed, 991
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