Pharmaceutical Law & Industry Report® Index-Summary

ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)

– Aplenzin ER, challenge to generic ANDA (D. Del.), 232
– Clobetasol propionate emulsion foam, 966
– Concerta generic challenge (D. Del.), 1504
– Diastat, 1095
– Hepsera, 1122
– Lovenox raw material released by FDA, 1459
– PhosLo GelCaps generic challenge (D. Mass.), 1145
– Protonix generic blocked (D.N.J.), 1105; ANDA accepted, 1355
– Vytorin generic ANDA (D.N.J.), 7
– Welchol generic challenge (D. Del.), 1504
– Xyzal ANDA stayed (E.D.N.C.), 1617

ABILIFY

– Schizophrenia drug patent enforceable (D.N.J.), 1458

ACCOLATE

– Zafirlukast generic, no infringement (D.N.J.), 1497

ACCUTANE

– Acne drug and depression, exclusion of causation evidence (N.J. Super. Ct.), 184
– Approval of NDA withdrawal, 1524
– Bowel disease damages award (N.J. Super. Ct.), 238

ACETADOTE

– Applications, 1121; new indications, 1633

ACTEMRA

– Arthritis drug approved, 73

ACTHAR

– Infantile spasm drug application, 25; FDA panel report, 660; action date extension, 795; more time, 1195

ACTIMMUNE

– Marketing, putative class action (N.D. Cal.), 1182
– Off-label use, proof of damages (N.D. Cal.), 1462; DOJ memo, 1616

ACTOPLUS

– Diabetes generic settlement (S.D.N.Y.), 644

ACTOS

– Diabetes drug and bladder cancer risk, 1233
– Generics

– – Dr. Reddy's generic challenge (S.D.N.Y.), 717
– – Ranbaxy generic settlement (S.D.N.Y.), 353
– – Watson generic settlement (S.D.N.Y.), 353

ACUROX

– Pain drug, FDA panel rejects, 566

ADVERSE EVENTS

See also SAFETY
– Bar codes and drug errors, 691
– Benicar and cardiovascular events, 786
– First quarter reports, 686
– Genetic basis for events, 254
– Matrixx Initiatives non-reporting (U.S., brief filed), 1143; (brief filed), 1470
– Pfizer non-reporting, FDA warning, 790

ADVERTISING

– Altabax misleading brochure, 599
– Aricept, TV commercials cited by FDA, 253
– Clinical efficacy, labels and ads, 1558
– Colchicine false advertising suit (D.N.J.), 199
– Comments on direct-to-consumer ads sought by FDA, 1151
– Coupons and DTC ads, FDA seeks comments, 1226
– Derma-Smoothe misleading website, 1593
– Expanded direct-to-consumer ads and drug spending, 691
– Gelnique restroom stall ads, 1593
– Gleevec misleading website, 599
– Italy, OTC ads, 1236
– Luvax patient brochure, FDA warning letter, 962
– Patient brochures, videos, waiting room sign, FDA warns firms, 166
– Photofin website, FDA warning, 1034
– Promotional e-mails and webpages, violation letters, 528
– Protonix generic, false advertising suit dismissal (E.D. Mich.), 313
– RE Methylphen Lanham Act suit (D. Md.), 1081
– Remicade direct advertising, no learned intermediary (Tex. App.), 317
– Reorganization plan for FDA, 243
– Reporting misleading ads, 629
– Risk information and direct-to-consumer ads, 864
– Seroquel, FDA says materials misleading, 1062
– Side effects disclosure, proposed FDA rule, 424
– Sleep drug TV ads, FDA violation letters, 791
– Social media

– – Drug promotion, 819
– – FDA policies, 866

– Tasigna website, FDA letter, 1061
– Va. consumer protection law and drug (W.Va.), 1619
– Zyflo CR ads, FDA letter, 899

AFREZZA

– Inhalation powder application, 73; no approval, 368; more time needed, 1636

AIDS AND HIV

– African access to drugs, 1527
– Colcrys dosing, 632
– Diluted drugs (C.D. Cal.), 240
– Efavirenz approval, 25
– Effectiveness evaluation methods (U.S., rev grant), 1394
– Egrifta application, 728; approval, 1474
– Fuzeon infringement settlement (E.D.N.C.), 1246
– HHS FY2011 budget, 1109
– Invirase and heart risk, 1376
– J&J overcharging suit (C.D. Cal.), 1621
– Nelson seeks drug funding, 1109
– Norvir, 219
– Pricing suit (C.D. Cal.), 1502
– Reyataz

– – Generic approval, 1290
– – Group facilities, maker barred, 1032

– Strides Acrolab product, 44
– Sustiva, 218
– Videx

– – Approval, 531
– – Liver disorder, 171

– Viread, 173

ALDARA

– Skin cream generic infringement settlement (D.N.J.), 516
– Topical cream, generic challenge (D.D.C.), 945

ALIMATA

– Chemotherapy patent upheld (D. Del.), 1499

ALLEGRA

– Antihistamine, generic blocked temporarily (D.N.J.), 744; barred, 773

ALLERGAN

– Dry eye treatment patent settlement (E.D. Tex.), 747

ALTABAX

– Skin infection treatment, misleading brochure, 599

AMPHETAMINE SULFATE

– Withdrawn from sale, 1475

ANDROGEL

– Testosterone replacement drug reverse payments, dismissal of FTC suit (N.D. Ga.), 229

ANEMIA DRUGS

– Procrit, qui tam suit partial dismissal (U.S., rev sought), 37; Solicitor Gen. input sought, 231; (rev den), 810
– Safety, FDA meeting, 70; approval of risk management program, 209

ANGIOMAX

– Anticoagulant, PTO refusal to extend patent term (E.D. Va.), 154; vacated, 350; extension ordered, 713; filing timely, 1050; no appeal, 1320
– Infringement claim (D. Del.), 1144
– Interim patent extension granted, 395

ANTIBIOTICS

– Generics

– – Merrem I.V., 827
– – Norfloxacin, Canadian generic delay (Fed. Ct.), 502
– – Vision loss (M.D. Ga.), 355

– Levaquin

See LEVAQUIN

– Noninferiority trials, FDA guidance, 1516
– Patents

– – Cefaclor infringement claim (Fed. Ct. App.), 1327
– – Licensing, 1529
– – Omnicef, no infringement (U.S., rev den), 59

– TOBI false claims settlement, 586
– Trovan

See TROVAN

ANTIDEPRESSANTS

– Aplenzin ER, challenge to generic ANDA (D. Del.), 232
– CPI-300, 219
– Effexor

See EFFEXOR

– Oleptro, 1064
– Paxil

See PAXIL

– Process patent invalid for obviousness (S.D.N.Y.), 809
– Wellbutrin

See WELLBUTRIN

ANTITRUST

– Cancer drugs indirect purchaser suit (D.N.J.), 782
– Cipro

See CIPRO

– Citalopram maker under investigation by EU, 75
– Community CarePartners discount program, 896
– CVS Caremark merger, antitrust issues, 1472
– Direct purchasers sham litigation (N.D. Ga.), 1211
– Ethypharm suit against Abbott (D. Del.), 1506
– Flonase “brand maturation” (E.D. Pa.), 1464
– Generic drugs

– – 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

– Inflated pricing, pass-on defense (Cal.), 914; effect of ruling, 958; trial ordered (Cal. Ct. App.), 1183
– Joint drug supplier quality and safety audit, 1225
– K-Dur purchasers settlement challenge (D.N.J.), 411; appeal, 519
– Latanoprost Italian antitrust probe, 1479
– Lovenox interlocutory appeal (D.N.J.), 1213
– Mergers and acquisitions

See MERGERS AND ACQUISITIONS

– Mexico, firms fined, 295; appeal denied, 869
– MiraLax direct purchasers' suit (D. Del.), 678
– Monopolies

– – Patent ductus arteriosus drugs (D. Minn.), 1176
– – Secondary wholesaler claim (2nd Cir.), 852

– Norvir predatory pricing (N.D. Cal.), 781
– Prandin anticompetitive conduct suit (D. Minn.), 1580
– Provigil

– – Reverse payments (N.D. Ohio), 748
– – Settlements challenge (E.D. Pa.), 412

– Reverse payments

– – AndroGel, dismissal of FTC suit (N.D. Ga.), 229
– – Circuit split, 1299
– – Provigil (N.D. Ohio), 748
– – Settlements, BNA Insights, 732

– Subpoena proper (D.D.C.), 979
– Temodar, illegal patent extension allegations (D. Del.), 316
– Unenforceable patents, direct buyer plaintiffs standing (U.S., rev den), 852
– Wellbutrin

– – Direct purchaser rep dismissal (E.D. Pa.), 984
– – Indirect purchaser suit (E.D. Pa.), 1215; end-payers, no certification, 1305
– – Sham patent litigation alleged (E.D. Pa.), 1179; reconsideration denied, 1431

ANX-530

– Cancer drug application, 45; filing refusal, 332; new name, 370

ANZEMET

– Cancer drug heart risk, 1632

APF530

– Nausea drug approval denied, 398

APLENZIN ER

– Antidepressant, challenge to generic ANDA (D. Del.), 232

APPLICATIONS

– Acetadote, 1121; new indications, 1633
– Acthar, 25; FDA panel report, 660; action date extension, 795; more time, 1195
– Acurox, FDA panel rejection, 566; NDA, 1636
– Afrezza, 73; no approval, 368; more time needed, 1636
– ANX-530, 45; filing refusal, 332; new name, 370
– APF530 rejection, 398
– ARC-4558, 1194
– Aricept patch, 1234
– Avastin and breast cancer, 961; removing indication from label, 1590
– Avodart, new indications, 1561
– Axanum response letter, 729
– AZ-004, 218; more data sought, 1322
– Benlysta, 759; priority review, 1122; extended review, 1564
– Biologics

– – Erwinase, 1443
– – Fabry disease treatment, 291
– – Filbrin Pad, 1529
– – Kidney transplants, 291
– – Krystexxa for gout, 369; approval, 1193; available, 1528
– – Neutroval biologics license, 170
– – Prevnar 13, 44
– – Privigen, 531
– – Simponi, 1260; new indication, 1476
– – T-DM1, 932; no fast track, 1162
– – Zalbin BLA, 794

– Brilinta, 1194; 1633
– Bromfenac ophthalmic solution, 25
– Bydureon NDA, 566; action date, 634
– Byetta, FDA response, 368; more data sought, 1353
– Capaxone formulation, 1633
– Ceftaroline, FDA panel recommendation, 1157
– Cephalon, 25
– Certriad, 433
– Chemosaturation system, 1636
– Cladribine tablets, 1528
– CM-AT, 256
– Contrave, 829; FDA panel report, 1562
– CPI-300, 219
– Cymbalta expanded indications, 1118
– Cysteamine eye drops, 662
– Daxas, FDA panel vote, 500; FDA questions, 1194
– DM-1756, 759
– Dyloject, 172
– Esbriet cleared by FDA panel, 332; no action, 603
– Exalgo, 218
– Exelbine, 568
– Exparel, 1594
– Ezogabrine, 1564
– Fidaxomicin, 1528
– Flutiform, 868
– Fortesta, 902
– Generic drugs

– – 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

– Giazo, 603
– Gilenia priority review, 252; cleared by FDA panel, 332
– Hexvix, FDA panel approval, 22; decision expected, 74
– Horizant denial, 253; FDA questions, 1443
– HSDD drug, FDA panel rejects, 825
– Illuvien, 1634
– Investigational products

See LEGISLATION, FEDERAL, HR 4732

– Ipilmumab, 1097
– JZP-6, 257; 1326
– KRX-0401, 471
– Laviv application, 23
– Linjeta, 1415
– Lorcaserin, 24; goal review date, 294; more data sought, 1378; new submission, 1632
– Luliconazole, 173
– Lupron Depot, 370
– Lurasidone, 371
– Lyrica application, 23
– Motavizumab, 45; FDA panel rejects, 757; more data sought, 1162
– Myocet, 74
– Naproxcinod, FDA panel rejection, 658
– Neupro, 569
– Neutroval, 1290
– Nexium response letter, 729
– Northera, 1637
– Nuvigil, 433; second response letter, 1636
– Ofirmev, 218; resubmission, 531
– Omapro, 397
– Palomid 259 IND, 191
– Parallel review by FDA and CMS, 1223; clinical evidence demand, 1286; PhRMA comments, 1629
– Pirfenidone priority review, 43
– Pixantrone, 293
– Pixuvri, 397; appeal, 1561
– Potigq, FDA panel vote, 1095
– Pradaxa, FDA panel vote, 1232
– Prevnar 13 application, 44
– Prolia, 256
– Proscar, new indications, 1561
– Provisional application period extension, 462
– PSI-7977, 1097
– Qnexa, 24; more data sought, 1409; briefing document, 1591
– Remoxy, 1636
– Replagal application, 23
– Retigabine, 45
– RG2833, 662
– Snow delays at FDA, 212
– Sprycel new indications, 931
– Stedesa, 173
– Taliglucerase alfa, 568; accepted for review, 931
– Tapentadol, 1290
– Tarcera expanded use, 22
– Tasigna, 256
– Tecarfarin development pathway, 44
– Telaprevir, 1529
– ThermoDox, 1121
– Tideglusib, 1195
– Vandetanib, 1260
– VIAject, 45; NDA, 294
– Vilazodone, 401
– Vivitrol, 532; priority review, 730
– XiDay, 335
– Zelrix, 1416
– Zenvia, 662
– ZSP-6, FDA panel rejection, 1117

APPROVALS

See also APPLICATIONS
– Accutane NDA approval withdrawal, 1524
– Acetaminophen IV, 1412
– Actemra, 73
– Afinitor, 1443
– Aricept doses, 1000
– Asclera for varicose veins, 432
– Axiron, 1525
– Bacitracin, 633
– Belatacept, 603
– Benicar, 218
– Benlysta, FDA panel recommends, 1474
– Botox for migraines, 1352
– Bromday, 1355; exclusivity, 1476
– Cayston, 256
– Ceftobiprole, no approval, 43
– CIP-Tramadol ER, 633
– Crestor, broader indications, 190
– Cuvposa oral solution approved, 1033
– Cymbalta expanded indications approval, 1442
– Dacogen regimen, 370
– Daytrana, 901
– Differin, 401
– Dulera, 868
– Efavirenz, 25
– Egrifta for lipodystrophy in HIV patients, 1474
– Ella, 1094
– Eloxatin, stay to end (D.D.C.), 1018
– Everolimus, 1416
– Exalgo, 335
– Famvir approval challenge (D.D.C.), 1244
– Faslodex, 1195
– Fludarabine phosphate injection, 1290
– Gamunex-C, 1244
– Gardasil for anal cancer prevention, 1634
– Generic drugs

– – 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
– – User fees and quicker approvals, 1224; reopened comment period, 1434
– – 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

– Gilenya for MS, 1233
– GoLytely, 173
– Halavan for breast cancer, 1474
– Herceptin, 1381
– Hizentra, 335
– Industry relationship with FDA, 1526
– Jalyn, 794
– Jevtana for prostate cancer, 825
– Juvederm XC, 172
– Kaletra, 568
– Kapvay, 1290
– Kombiglyze XR, 1443
– Krystexxa for gout, 1193; available, 1528
– Lamictal XR, 173
– Latuda for schizophrenia, 1410
– Lidocaine with dermalfilters, 191
– Lifesaving drugs, speedier approvals sought, 792
– Lo Loestrin FE, 1381
– Lumigan, 1161
– Lumizyme, 688
– Midodrine approval withdrawal, 1096
– Mirapex, 256; extended release, 401
– Morphine sulfate ban (D. Wyo.), 980
– Namenda XR, 827
– Natazia, 632
– Nexterone, 1529
– Noninferiority trials, FDA policy, 1154
– Norvir, 219
– NovoSeven RT, 1063
– Nuedexta, 1416
– Octaplex, 1528
– Oleptro, 191
– Optical imaging agent, 730
– Oravig, 532
– OxyContin, new formulation, 467
– Pancrease, 500
– Pixantrone, 335
– Posting of safety reports by FDA, 784
– Pradaxa, 1354
– Prolia for osteoporosis, 729
– Protopam Chloride pediatric use, 1194
– Provenge, FOIA (6th Cir.), 203; approval, 598
– Removing unapproved drugs from market (D. Wyo.), 1500
– Retrospective analysis of cancer drug approvals, 250
– Rituxan approved, 254
– Safyral, 1637
– Saphris, 1161
– Silenor, 401
– Solodyn, 1161
– Spiriva HandiHaler, 25
– Sprix, 662
– Sprycel for blood cancer, 1411
– Staxyn, 828
– Stedesa, 603
– Strides Acrolab HIV product, 44
– Success rates of top firms, 1191
– TachoSil patch for cardiovascular surgery, 470
– Tarceva, 532
– Tasigna broader indications, 824
– Taxotere, 1064
– Teflaro for bacterial infections, 1411
– Tekamlo, 1162
– Trelstar formulation, 368
– Tribenzor for blood pressure, 998
– Tykerb for breast cancer, 169
– Valcyte, 1063
– Veletri, 1121
– Vimovo, 603
– Vivitrol for opiod dependence, 1231; approved, 1323
– VPRIV, 293
– Vyvanse for ADHD, 1476
– Withdrawn approvals

– – Midodrine, 1096
– – Unfiled annual reports, 1193

– Xeomin, 1035
– Xgerva for cancer bone injuries, 1524
– Xiaflex, 170
– Xifaxan for overt hepatic encephalopathy, 430
– Zortress, 569
– Zuplenz, 901
– Zyclara for actinic keratose, 431

ARALAST

– Alpha-1-proteinase inhibitor, misleading brochure, 1159

ARANSEP

– Anemia drug, false claims suit dismissal (D. Mass.), 581
– Kidney disease risk, 1353
– Off-label use suit dismissal (9th Cir.), 1363

ARAVA

– Rheumatoid drug and liver damage, 928

ARGATROBAN

– Anticoagulant generic barred (S.D.N.Y.), 810

ARICEPT

– Alzheimer's drug, TV commercials cited by FDA, 253
– Generic cleared, 1522; approved, 1523
– Higher dose, 1000
– Patents

– – Challenged (Fed. Cir.), 1300
– – Dismissal of declaratory judgment suit (M.D.N.C.), 1140
– – Infringement (D.N.J.), 887; stay and dismissal, 982

ARZERRA

– Antibody product, noninfringement declaration sought (N.D. Cal.), 233
– Leukemia drug infringement claim (S.D. Cal.), 416

ASCLERA

– Varicose vein treatment approval, 432

ASP (AVERAGE SALES PRICE)

See PRICING

AUSTRALIA

– Vioxx not fit for purpose, 372

AVANDIA

– Access restricted, heart attack and stroke risks, 1229
– Clinical trials, suspension request, 658
– Concealment of risk alleged (E.D. Tex.), 1555
– Diabetes drug, diversity jurisdiction (S.D. Ill.), 626
– Joinder upheld, remand (E.D. Mo.), 890
– Most suits settled, 959
– Santa Clara, Cal., suit over warnings (N.D. Cal.), 355
– Utah Medicaid suit (Utah Dist. Ct.), 1466

AVASTIN

– Breast cancer indications, 961; removing from label, 1590

AVODART

– Prostate cancer drug, new indications, 1561

AWP (AVERAGE WHOLESALE PRICE)

See MEDICAID

AXIRON

– Testosterone deficiency drug approval, 1525

AZ-004

– Schizophrenia drug application, 218; more data sought, 1322