Pharmaceutical Law & Industry Report® Index-Summary

GAMMAGARD

– Immune globulin IV lots withdrawn, 759

GARDASIL

– HPV vaccine approval for anal cancer prevention, 1634

GELNIQUE

– Overactive bladder restroom stall ads, 1593

GEMZER

– Cancer drug patent valid (S.D. Ind.), 453
– Method patent invalid (Fed. Cir.), 1013; rehearing denied, 1393

GENERIC DRUGS

– Actos

See ACTOS

– Allegra, generic blocked (D.N.J.), 744
– Analpram, 532
– Antibiotics, vision loss and generic (M.D. Ga.), 355
– Antitrust

– – AndroGel

– – – Overcharging, Supervalu suit (N.D. Ga.), 486
– – – Reverse payments, dismissal of FTC suit (N.D. Ga.), 229

– – Delays due to settlements, action sought, 69
– – Flonase “sham ” citizen petition allegations (E.D. Pa.), 153
– – Mirapex generic dispute (W.D. Pa.), 413
– – Pay-for-delay, Senate hearing, 785; House hearing, 989; savings cited, 996; revived Senate efforts, 1024; savings questioned, 1088
– – Provigil, subpoena upheld (D.D.C.), 1080
– – Toprol maker accused of blocking generics (D. Del.), 515
– – TriCor settlement (D. Del.), 59

– Applications

– – Aldara generic challenge (D.D.C.), 945
– – Effexor XR, 634; approved, 899
– – Protonix generic blocked (D.N.J.), 1105; ANDA accepted, 1355
– – Trandate, 219
– – Withdrawals not due to safety, 1060

– Approvals

– – Aceon, 173
– – Actigall, 335
– – Adalat, 1594
– – Adenoscan, 569
– – Aldara, 1160
– – Ambien, 1354
– – Aricept generic cleared, 1522; approved, 1523
– – Arimidex for breast cancer, 253; Roxane generic, 932
– – Cardizem, 370
– – Cozaar

– – – Actavis, 1325
– – – Mylan, 1355

– – Crestor, 1290
– – Cymbalta, 1529
– – Cytovene, 827
– – Diastat, 1095
– – Differin, 901
– – Evoclin, 471
– – Flomax

See FLOMAX

– – Hycamtin, 1528
– – Hydroxyzine hydrochloride, 829
– – Hypertension generics, exclusivity (D.C. Cir.), 451
– – Hyzaar

See HYZAAR

– – Imitrex

– – – Bedford, 1161
– – – Sagent, 1035

– – Kytril

– – – Sagent, 501
– – – Taro, 760

– – Lamisil, 795
– – Lopressor, 531
– – Lorazepam Intensol, 829
– – Lotrel, 219
– – Lovenox approval challenge (D.D.C.), 975; no withdrawal, 1138
– – Lunesta, 401
– – Merrem I.V., 827
– – Mesnex injection, 531
– – Mirapex, 1381
– – Monistat, 760
– – Nabumetone, 966
– – Namenda, 501
– – Neurontin, 760
– – Niravam, 370
– – NuLytely, 471
– – Pepcid, 902
– – Procardia XL, 868
– – Prograf

– – – Mylan, 1234
– – – Watson, 902

– – Reyataz, 1290
– – Rilutek, 1290
– – Sustiva, 218
– – Tofranil-PM

– – – Lupin, 531
– – – Roxane, 532

– – Toprol XL, 532
– – Tussionex, 1326
– – Valtrex

– – – Other firms, 730
– – – Watson, 692

– – Videx EC, 531
– – Wellbutrin, 501; new strengths, 965
– – Xanax, 828
– – Xyzal, 1524
– – Yasmin, no stay of approval (S.D.N.Y.), 1136
– – Zemuron, 1035
– – Zocor, 828
– – Zyban, 603

– Argatroban generic barred (S.D.N.Y.), 810
– Boniva generic blocked (D.N.J.), 1460
– CEO leaves industry group, 602
– Cipro pay-for-delay settlement upheld (2nd Cir.), 579; en banc review denied, 1130; (U.S., rev sought), 1579
– Concerta

See CONCERTA

– Cubicin copy challenge, 1561
– Desoxyn, 569
– Effexor

See EFFEXOR

– Eloxatin

See ELOXATIN

– European Union (EU)

– – Delaying generics, decline in patent settlements, 903
– – India, generic drug seizures, 664; deal with EU, 1382
– – Monetary incentives, 570
– – Raids launched, 1565
– – Seizures in transit, 664

– Evista generic challenge (S.D. Ind., D. Nev.), 621
– Exelon, 902
– Flomax

See FLOMAX

– Flonase “brand maturation” (E.D. Pa.), 1464
– Impurities, FDA guidance, 1517
– India, EU seizures, 664; deal with EU, 1382
– International developments

– – Canada

– – – Atomoxetine generic challenge (Fed. Ct.), 1477
– – – Concerta generic cleared (Fed. Ct.), 693
– – – Confidentiality order, application (Fed. Ct.), 761
– – – Glaucoma drugs, challenge (Fed. Ct.), 1445
– – – Norfloxacin generic delay (Fed. Ct.), 502

– – EU

See European Union (EU), this heading

– – France, efforts to block generics, 693

– Lipitor

See LIPITOR

– Lovenox generic announced, 995
– Medicaid

– – Rates, GAO report, 1628
– – Savings and switching, 930; substitutions, 996

– Metaxalone generic blocked (D.N.J.), 641
– Metoclopramide failure to warn claims (U.S., rev sought), 677; (brief filed), 1086; DOJ position (brief filed), 1428; (rev grant), 1577
– Mirapex

See MIRAPEX

– Optivar, 901
– Oracea generic blocked, 887
– Patents

– – Accolate generic, no infringement (D.N.J.), 1497
– – ACTOplus settlement (S.D.N.Y.), 644
– – Aldara infringement settlement (D.N.J.), 516
– – Alimata patent upheld (D. Del.), 1499
– – Aplenzin ER, challenge to generic ANDA (D. Del.), 232
– – Atomoxetine generic challenge (Fed. Ct.), 1477
– – Boniva infringement claim (D.N.J.), 1137; summary judgment, 1182
– – Caduet generic, infringement suit (D. Colo.), 205
– – Carbatrol, generic patent dispute (D.N.J.), 386
– – Cipro patent suit dismissal (D. Md.), 552
– – Combigan

See COMBIGAN

– – Concerta generic challenge (D. Del.), 1504
– – Delay of market entry, 893
– – Eloxatin

See ELOXATIN

– – Enablex suit, dismissal (D. Del.), 1397
– – Entocort settlement (D. Del.), 643
– – Evoxac generic settlement (D. Del.), 1053
– – Exalgo generic challenge (D.N.J.), 1621
– – Exclusivity, FDA determination rule challenge (D.D.C.), 267; BNA Insights, 606; rehearing denied, 644
– – Famvir infringement settlement (D.N.J.), 207
– – Gemzer patent valid (S.D. Ind.), 453
– – Hectoral generic challenge (D. Del.), 682
– – Hyperparathyroidsim drugs (N.D. Ill.), 647
– – Integrilin infringement suit (D. Del.), 551
– – Lialda infringement alleged (D. Del.), 947
– – Lovenox copy challenge (D. Mass.), 1550
– – Lucox CR settlement (D. Del.), 1141
– – Lunesta, inequitable conduct claims (D.N.J.), 774; settled, 1054
– – Malarone infringement settlement (D. Del.), 485
– – Meridia, challenge to generic (D. Del.), 36
– – MoviPrep settlement (D.N.J.), 1144
– – Mucinex, generic no infringement (W.D. Mich.), 200; vacated, 1051
– – Namenda

See NAMENDA

– – Nexium

See NEXIUM

– – Nuvigil

See NUVIGIL

– – Oraped ODT infringement claim (D. Del.), 1620
– – Paxil, TRO denied (D.N.J.), 1340; no injunction, 1395
– – Prandin infringement suit dismissal (D.N.J.), 483
– – Prilosec infringement (Fed. Cir.), 5
– – Protonix patent valid (D.N.J.), 584; upheld, 941
– – Pulmicort generic blocked (Fed. Cir.), 1391
– – Renvela, generic challenge (D. Md.), 717
– – Restoril patent obvious, 586
– – Seasonique infringement claim (D. Nev.), 454
– – Simcor challenge (D. Del.), 623
– – Solodyn

See SOLODYN

– – Stalevo, infringement settlement (D.N.J.), 813
– – Strattera induced infringement claim (D.N.J.), 33; patent invalid, 1079
– – Tarka, no injunction (D.N.J.), 775
– – Treximet, generic challenge (E.D. Tex.), 485
– – Ultracet settlement (D.N.J.), 747
– – Uroxatral generic infringes (D. Del.), 642; patent upheld, 1106
– – Valcyte settlement (D.N.J.), 1142
– – Viagra infringement claim (E.D. Va.), 454
– – Vytorin generic challenge (D.N.J.), 1107
– – Welchol generic challenge (D. Del.), 1504
– – Yasmin

See YASMIN

– – Yaz generic challenge (D. Del.), 713
– – Zymar patent invalid (D. Del.), 851

– PhosLo GelCaps generic challenge (D. Mass.), 1145
– Pricing, effect of generics, 757
– Reglan

See REGLAN

– REMS, comments on FDA draft guidance, 41
– Revlimid, 1564
– Sandoz and Oriel, 531
– Savings, HHS report, 1626
– Subpoena for CEO (D.D.C.), 1553
– Timoptic-XE, 334
– User fees, planned FDA meeting, 1058; preparing negotiations, 1150; quicker approvals, 1224; reopened comment period, 1434
– Vigamox generic stayed (D. Del.), 1053
– Vytorin

See VYTORIN

– Wellbutrin, sham patent litigation alleged (E.D. Pa.), 1179; reconsideration denied, 1431
– Zetia

See ZETIA

– Zymaxid, 692

GENETICS AND BIOTECHNOLOGY

– Biosimilars

– – Biologics Price Competition and Innovations Act, BNA Insights, 698
– – BNA webinar, 1000
– – EU draft guidelines, 1530
– – Health reform implementation, 898
– – Investment in technology, 965
– – Meeting participation, 1560
– – Pathway, FDA efforts, 558; implementation issues, 688; practitioner comments, 865; guidance expected, 1230; hearing planned, 1280; biosimilar challenges, 1312; clinical trials, unique names sought, 1404; implementation challenges, 1514
– – Pfizer and Biocon collaboration, 1352
– – Stakeholders comments, 1403
– – 2010 FDA agenda, 630
– – Watson and Itero collaboration, 965

– Tailoring prescriptions to genetics, 758

GIANVI

– Contraceptive label corrections (N.D. Ill.), 814
– Patent infringement claim dismissal (D. Del.), 886

GILENYA

– MS drug priority review, 252; cleared by FDA panel, 790; approved, 1233

GLEEVEC

– Brazilian patent decision, 1382
– Gastrointestinal cancer drug, misleading website, 599

GNRH

– Prostate drug and diabetes, 591

GRANTS

– Comparative effectiveness, NIH research grants, 359
– Therapeutic discovery project program, 1408