Pharmaceutical Law & Industry Report® Index-Summary

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– – Data submission, FDA issues draft guidance, 471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
– – 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

See 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– Withdrawals not due to safety or effectiveness, FDA says, 19; 19 drugs withdrawn, 715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
– Failure-to-warn of suicide risk, maker wins summary judgment (11th Cir.), 705

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

ACULAR

– Eye inflammation treatment patent upheld (U.S., rev den), 117

ADVERSE EFFECTS

– Mixing prescription and OTC drugs, adverse reactions in seniors possible, 21

ADVERSE EVENTS

– Canada, reporting changes considered, 721
– Genetic basis for certain events, FDA releases data, 182
– Raptiva, FDA issues advisory, 233
– Toll-free number on medication guides, FDA issues guidance, 686

ADVERTISING

– Avodart, FDA says TV ad is misleading, 271
– Brazil revises rules, 27
– Depakote, FDA tells maker to pull misleading materials, 159
– 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
– Nexium, false advertising class action remanded (3rd Cir.), 587
– Protonix, generic advertising challenged (E.D. Mich.), 554
– Risk information

– – Draft guidance issued by FDA, 618
– – Lacking from many Internet ads, 413

– Ultram ER web video called misleading by FDA, 623
– Velcade maker accused of overstating efficacy, 746
– Yaz maker to submit TV ads to FDA, 189

AFINITOR

– Approved for kidney cancer, 383

AIDS AND HIV

– IDX889 licensing, In Brief, 191
– IQP-0410, In Brief, 49
– Kaletra, price cut in Mexico, 387
– Specialist firm planned, In Brief, 486

ALABAMA

– Medicaid

– – E-prescribing system announced, 648
– – 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

ALDARA

– Skin cancer cream blamed for severe symptoms, claim time-barred (D. Utah), 257

ALLEGRA-D

– Allergy drug maker tries to block generic (D.N.J.), 119

ANALYSIS & PERSPECTIVE

– De-identified health information and state regulation, 422
– Federal preemption in drug and device suits, 106
– Foreign Corrupt Practices Act compliance, 215
– Patents

– – Reversing patent settlements, 749
– – Risk evaluation and mitigation strategy patents, 28

– Phenergan failure to warn claim, 353; effect on preemption defense, 658
– Trademarks, proving use, 52

ANDAs

See ABBREVIATED NEW DRUG APPLICATIONS (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

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

See DORYX

– Flucloxacillin associated with liver damage, 652
– HGS and Morphotek, In Brief, 386
– Plectasin NZ2114, In Brief, 25
– Trovan maker accused of violating international norms (2nd Cir.), 147

ANTIDEPRESSANTS

– Consolidation of product liability claims denied (D. Mo.), 639
– Failure-to-warn of suicide risk, preemption ruling remanded (U.S.), 280; vacated and remanded (3rd Cir.), 497; briefs filed, 498
– Lexapro approved for adolescents, 350
– Paxil

See PAXIL

ANTITRUST

– 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
– BMS to settle with states over court order violations, 12
– Cipro settlement challenged (U.S., rev den), 730
– CVS Caremark merger, FTC probe sought, 565; pharmacists group alleges monopoly, 565
– 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
– Nifedipine direct purchasers class action certified (D.C. Cir.), 229
– 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

– Tricor, consumer suit over generic delay, settlement approved (D. Del.), 500
– Wellbutrin, direct purchaser antitrust suit may proceed (E.D. Pa.), 308

APPLICATIONS

– Acetavance, In Brief, 596
– Acurox, In Brief, 51; 272; 747
– Afresa, In Brief, 324; new application, In Brief, 595
– Apirin-ulcer drug combo, In Brief, 541
– AR-12, In Brief, 570
– AR-42, In Brief, 324
– Arzerra, In Brief, 164; called safe and effective by FDA panel, 649; review extended, In Brief, 720
– Bepreve, In Brief, 105
– Botox, In Brief, 626
– Cefazolin, In Brief, 655
– Certriad, In Brief, 692
– Cervarix, In Brief, 385
– Cimzia, FDA wants more data, 46
– Cinryze

See CINRYZE

– Colitis drug, FDA wants more data, 46
– Cymbalta, In Brief, 655
– Denosumab, In Brief, 24
– Diabetes treatment, FDA to apply guidance, 295
– Durezol, In Brief, 324
– DX-88, In Brief, 385
– Erbitux, In Brief, 134
– Exenatide, In Brief, 541
– Fampridine-SR, In Brief, 385; 571
– Fenretinide, In Brief, 450
– Flutiform, In Brief, 627; FDA may need more data, In Brief, 691
– 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, In Brief, 719
– Invega, In Brief, 191
– Isolagen Therapy, In Brief, 298
– LiquiXR, In Brief, 570
– Loramyc, In Brief, 720
– Lucassin, In Brief, 719
– Lumizyme, FDA seeks more information, 270
– MonoSol XR, In Brief, 451
– Nexium, In Brief, 25
– NGX-4019, In Brief, 25
– Nonsteroidal anti-inflammatory drug, 418
– Ondansetron ODFS, In Brief, 691
– Onglyza timeline extended, 513
– Onrigin, In Brief, 212; application accepted, 486
– Pegloticase, In Brief, 50; 51
– Pixantrone, In Brief, 134; rolling submission, In Brief, 451; priority review sought, In Brief, 747
– PN 400, In Brief, 596
– PolyHeme not approved, In Brief, 542
– Reloxin, In Brief, 78
– Restanza called safe, but not effective by FDA panel, 649
– Rexin-G, In Brief, 720
– Rezonic, In Brief, 747
– Risperdal, In Brief, 213
– Rituxan, In Brief, 595
– ROX-888, In Brief, 192
– Saphris, In Brief, 105; 238
– Seroquel XR, In Brief, 24
– Stelara, In Brief, 626
– Sunitinib, In Brief, 595
– Surfaxin, FDA wants more data, 477
– Symbicort, In Brief, 418
– Tarceva, In Brief, 352
– Tykerb, In Brief, 384
– Tyvaso, In Brief, 324; 515
– Ustekinumab, In Brief, 25
– Xiaflex, In Brief, 515
– XP12B, In Brief, 419
– Zegerid, In Brief, 164
– Zenpep, In Brief, 747
– Zogenix, In Brief, 212
– Zyprexa, In Brief, 78

APPROVALS

– ACTOplus met, In Brief, 569
– Adcira, In Brief, 626
– Apidra SoloSTAR, In Brief, 272
– Atryn approved by FDA, 190
– Avastin, FDA panel favors approval for brain cancer, 381; approved, 540
– Average approval time down at FDA, development time up, 74
– Axert, In Brief, 692
– Azor, In Brief, 570
– Besivance approved, 651
– Cimzia, In Brief, 596
– CIP-Tramadol ER, In Brief, 212
– Citizen petitions, FDA issues draft guide, 122
– Coartem tablets approved for malaria infections, 416
– Creon, In Brief, 541
– Degarelix approved, 22
– DX-88, FDA panel favors approval, 188
– Fanapt approved for adult schizophrenia with warning, 539
– Gelnique, In Brief, 134
– Generics

See GENERIC DRUGS

– Gleevec approved, 23
– Ibuprofen Injectable dosage approved by FDA, 717
– Ilaris, In Brief, 748
– Kapidex, In Brief, 164
– Krystexxa, In Brief, 719
– Lamictal XR, In Brief, 656
– Lexapro approved for adolescents, 350
– Multaq, FDA panel favors approval, 350
– Nexterone, In Brief, 50
– Onglyza, FDA panel favors approval, 414
– Prasugrel, FDA panel favors approval, 159; consumer group opposes, 649
– 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
– Rivaroxaban gets favorable review from FDA panel, 351; gets complete response letter, 650
– Ryzolt, In Brief, 51
– Sabril cleared by FDA panel, 73
– Samsca, In Brief, 627
– Sanvar, In Brief, 627
– Savella, In Brief, 105
– Silenor application rejected by FDA, 446
– Simponi for arthritis, 513
– Symbicort, In Brief, 272
– Symbyax, In Brief, 352
– Tygacil, In Brief, 352
– Uloric, In Brief, 212
– Vancomycin, In Brief, 570
– Vectical, In Brief, 163
– Zingo, In Brief, 77
– Zipsor, In Brief, 748
– Zolpimist, In Brief, 24
– Zyprexa, In Brief, 352

ARANESP

– Anemia drug off-label use class action dismissed (C.D. Cal.), 730
– Illegal marketing alleged (D. Mass.), 255

ARBITRATION

– Remicide distribution agreement, arbitration sought, 622

ARZERRA

– Leukemia drug, In Brief, 164; called safe and effective by FDA panel, 649

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

AVASTIN

– Brain cancer treatment, FDA panel favors approval, 381; approved, 540
– CalPERS approves for ovarian cancer, 296

AVODART

– Prostate treatment, FDA says TV ad is misleading, 271

AZOPT

– Eye drug maker alleges infringement (E.D. Tex.), 119