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ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)

– Decongestant, In Brief, 1129
– Flomax generic ANDA, Impax sued (N.D. Cal.), 882
– Forfeiture provisions for first ANDA applicants 180-day exclusivity, Analysis & Perspective, 371
– Generic drugs

– – Abilify ANDA challenged (D.N.J.), 1185
– – Ambien CR, generic ANDA challenged (D.N.J.), 320
– – Argatroban, generic ANDA challenged (S.D.N.Y.), 44
– – Depakote generic, withholding of approval upheld (D.C. Cir.), 473
– – Entocort

See ENTOCORT

– – Nexium ANDA challenged (D.N.J.), 1184
– – Plavix generic ANDA approval challenged (D.D.C.), 506
– – Prevacid generic challenged (D. Del.), 706
– – Seasonique, infringement by generic ANDA alleged (D.N.J.), 321

– Inderal not withdrawn for safety or effectiveness, FDA says, 51
– Previously approved products ANDAs may proceed, not withdrawn for safety, 302
– Sensipar, generic ANDA challenged (D. Del.), 883
– Seroquel withdrawal not due to safety, FDA says, 137
– Tequin withdrawn due to safety issues, 1040

ABILIFY

– Antipsychotic expanded indications, In Brief, 588
– Generic maker accused of infringement (D.N.J.), 420
– Off-label use, maker settles allegations, 387

ABRAXANE

– Breast cancer drug maker to appeal $55M infringement award (D. Del.), 702

ACCREDITATION

– Pharmacies, URAC seeks public comments, 138
– Quality initiative, 7 firms seek URAC accreditation, 919

ACCUTANE

– Acne drug blamed for IBS, $10M awarded (N.J. Super. Ct.), 508
– Expert testimony excluded, summary judgment for maker affirmed (11th Cir.), 997

ACIPHEX

– Ulcer drug patent valid and enforceable (Fed. Cir.), 845

ACTEMRA

– Arthritis drug, FDA panel recommends approval, 891

ACTIMMUNE

– Off-label uses, former CEO indicted for promoting (N.D. Cal.), 321

ACTONEL

– Bone-blocking drug, generic version challenged (D. Del.), 1117
– Infringement alleged (D. Del.), 445
– Osteoporosis drug patent upheld against generic maker (D. Del.), 253

ACTOS

– Active ingredient, patent valid (Fed. Cir.), 386

ACULAR

– Eye inflammation treatment patent upheld (Fed. Cir.), 815; rehearing denied, 1023

ADDERALL

– ADD drug infringement, summary judgment denied (D. Colo.), 1111

ADVERSE EFFECTS

– Advertising, side effects hotline urged for TV ads, 606
– Baycol user cannot recover Medicare expenses for services needed after adverse reaction (8th Cir.), 46
– Chantix, serious effects reported, 638
– Heparin

See HEPARIN

– Myobloc and Botox adverse reactions, FDA urged to increase warnings, 135; FDA to review, 186
– Side-effect notification number for patients, pharmacists have one year to comply under FDA rules, 47

ADVERSE EVENTS

– Biologics, FDA seeks public comments on reporting requirements, 209
– BNA plans audioconference, In Brief, 665
– Heparin suspended by maker due to adverse events, 187
– Mass. hospitals' drug errors, effect reported, 214
– MedWatch forms, FDA seeks comments, 188
– Raptiva maker sends letter to providers, 1157

ADVERTISING

See also MARKETING
– ADHD, FDA warns firms about misleading ads, 1125
– Avinza promotional materials ordered pulled, 403
– Bystolic ads, FDA issues warning letter, 1039
– Dingell (D-Mich) and Stupak (D-Mich) seek reduction in deceptive ads, 607
– Direct-to-consumer ads

– – Ban

See LEGISLATION, FEDERAL, HR 6151

– – Democrats want restrictions, 576; firms accept two suggested ad practices, 712
– – Dingell (D-Mich) and Stupak (D-Mich) question FDA ties to industry, 1187
– – Effect on sales reported, 1010
– – Lipitor, Jarvik commercials questioned by House panel, 49; ads pulled, 245
– – Outlook 2008, 77
– – TV ads

– – – Consumers Union wants FDA contact information, 409
– – – Side effects hotline urged, 606

– – User fees for reviewing will not be implemented, FDA says, 69
– – Web site launched to educate public, 1041

– Fictitious drugs, FDA to use in test ads, 943
– Paxil deceptive ad alleged, collateral estoppel no bar to class action (Cal. Ct. App.), 1143
– Warning letters increase, FDA changing enforcement approach, 742
– Yaz misleading TV ads, FDA warns maker, 1188

AIDS AND HIV

– Genetic tests urged to avoid drug hypersensitivity reactions to drugs, 886
– Intelence approved for HIV, 109
– Lexivia, In Brief, 665
– Prezista

See PREZISTA

– Pricing class action, settlement proposed (N.D. Cal.), 904; agreement reached on issues for appeal, 957
– Safety of HIV drugs, heart attack risk reported, 399
– Tenofovir patent denied in Brazil, 1043
– Viread, Brazilian ministry seeks to block patent, 461

AIR INSULATION

– Termination of development announced, 303

ALABAMA

– Medicaid inflated prices

– – Atty. Gen. offers to settle with firms, 795
– – Dey LP and Takeda settle (Ala. Cir. Ct.), 41
– – $215M awarded (Ala. Cir. Ct.), 233

ALASKA

– Controlled substances database established, 747
– Zyprexa maker to settle marketing charges (Alaska Super. Ct.), 346

AMIODARONE

– Rhabomyolysis risk, FDA warns, 943

AMITIZA

– IBS drug approved, 520

AMNEAL

– Infection treatment generic approved, 586

ANALYSIS & PERSPECTIVE

– Anti-kickback laws, enforcement and legislative developments, 274
– Comparative effectiveness, role and scope, 1160
– E-prescription incentive payments, 893
– Forfeiture provisions for first ANDA applicants 180-day exclusivity, 371
– Hatch-Waxman and declaratory judgments, 1069
– Mircera patent infringement, 977
– Norvir antitrust litigation, 721
– Overfill issues raised, 863
– Patents

– – Maximizing patent protection, 782
– – Obviousness and chemical structure patents, 525
– – Secondary drug patents after KSR ruling, 82

ANDAs

See ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)

ANEMIA DRUGS

– Cancer patients

– – FDA reviewing new safety data, 47; panel recommends restrictions, 324
– – Mortality and blood clot risks reported, 244

– Labels and warnings

– – Clarification of approved conditions ordered by FDA, 886
– – Revisions, FDA announces, 294

– Medicare drug coverage

– – CMS may review, 917
– – Corrections urged, 211

ANTI-KICKBACK LAWS

– Electronic kiosk offering services to patients, no kickback HHS IG rules, 240; clarification, 265
– Enforcement and legislative developments, Analysis & Perspective, 274
– False claims, kickbacks by drug makers to hospitals established by whistleblower, motion to dismiss denied (D. Mass.), 235
– HMOs, kickbacks by drug maker alleged, facts not sufficient (E.D. Tex.), 1114
– Medicaid, Merck settles claims of kickbacks and improper price reports, 175
– Procrit off-label promotion and kickback claims, whistleblower action dismissed (D. Mass.), 148

ANTIBIOTICS

– Access and approval

See LEGISLATION, FEDERAL, S 3549

– Antitrust, Cipro settlement challenged (Fed. Cir.), 125
– Floxin otic, patent validity ruling reversed (U.S., rev den), 200
– Incentives

See LEGISLATION, FEDERAL, S 3560

– Inflated prices alleged, dismissal denied (D. Mass.), 850; plaintiffs may submit claims, 1055
– Ketek

See KETEK

– Levaquin blamed for tendon rupture, change of venue denied (D. Minn.), 350; suits consolidated, 766
– Maxipime, FDA reviewing safety data, 580
– Safety

– – Boxed warning on tendon risk sought by FDA, 803
– – Doribax, FDA panel votes for efficacy and safety of new indications, 861
– – Public Citizen seeks action, sues FDA (D.D.C.), 41
– – Tendon risk warning sought by FDA, 803

– Zithromax, generic approved, In Brief, 220

ANTIDEPRESSANTS

– Cymbalta blamed for suicide, failure-to-warn claim rejected (E.D. La.), 627
– Effexor

See EFFEXOR

– Failure-to-warn of suicide risk, federal law preempts claim (3rd Cir.), 417; rehearing sought, 501; (U.S., rev sought), 1180
– Paxil

See PAXIL

– Positive studies more likely to appear in medical literature, 108
– Pristiq

See PRISTIQ

– Seroxat maker accused of failing to disclose evidence of suicide risk, no charges planned in U.K., 307

ANTITRUST

– Arava, drug direct purchasers claim may proceed (S.D.N.Y.), 93; maker accused of filing sham citizen petition with FDA, 1204
– Cancer drug maker settles dispute over alleged discounts to oncology clinic (D.N.J.), 819
– Cipro settlement challenged (Fed. Cir.), 125
– Ciprofloxacin patent settlement not anticompetitive (Fed. Cir.), 1199
– Generic drugs

– – Delays, FTC says brand-name makers paying generic makers, 629
– – Provigil maker accused of anticompetitive product in trying to block generic (D.D.C.), 201; transferred, 503
– – TriCor maker and French firm accused of trying to block generic (D. Del.), 318; more states join suit, 475

– Nexium aggressive marketing, drugstores antitrust suit dismissed (D.D.C.), 228
– Norvir

See NORVIR

– Pricing

See PRICING

– Rx.com suit against PBMs dismissed (E.D. Tex.), 319; appeal planned, 444
– Thalomid patent infringement, bifurcation of antitrust and unfair competition counterclaims rejected (D.N.J.), 701
– Tiazac, wholesalers' antitrust claims dismissed (D.C. Cir.), 873
– TriCor suit arbitrarily divided by time frame to avoid federal jurisdiction (E.D. Tenn.), 1145
– Venofer sublicense needs revision (FTC), 1054
– Videotaping of execs during FTC probe approved (D.D.C.), 654
– Wellbutrin

See WELLBUTRIN

APPLICATIONS

– Acetavance, In Brief, 920
– Aciphex, In Brief, 272
– Actemra, In Brief, 1099
– Aczone, In Brief, 336
– Advexin, In Brief, 1012
– Akten, In Brief, 692
– Alogliptin, In Brief, 52; 1192; Alogliptin/Actos combo pill, In Brief, 1097
– Ampligen, In Brief, 807
– Astelin, In Brief, 665
– Azor, In Brief, 1064
– Aztreonam lysine, In Brief, 1064
– Bazedoxifene, In Brief, 642
– Bimatoprost, In Brief, 665
– Bucindolol, In Brief, 1098
– Cethromycin, In Brief, 1128
– Cimzia, In Brief, 165
– CloniBID, In Brief, 246; 491
– Cymbalta, In Brief, 666
– Dalbavancin HCl, FDA seeks more data on skin infection treatment, 27
– Dalbavancin, In Brief, 1042
– Doribax, In Brief, 305; 1013
– Doxil-Taxotere, In Brief, 1042
– DX-88, In Brief, 1129
– Entereg

See ENTEREG

– Fablyn, In Brief, 140
– Frova application withdrawn, 430
– Gamunex, In Brief, 588
– Gardasil, In Brief, 335
– Genasense, In Brief, 73; 336
– Hydrocodone and acetaminophen, In Brief, 1222
– Iclaprim, In Brief, 614
– Imagify, In Brief, 522
– Intermezzo, In Brief, 1128
– Ipilimumab, In Brief, 522
– Isonep, In Brief, 460
– Kynapid, FDA wants more information, 947
– Liraglutide, In Brief, 642
– Milnacipran, In Brief, 1222
– Mozobil, In Brief, 719
– Multaq, In Brief, 614; 948
– Myozyme

See MYOZYME

– Nebido, In Brief, 1129
– NGX-4010, In Brief, 1221
– Ofloxacin ophthalmic, In Brief, 459
– OGX-011, In Brief, 1013
– Oritavancin, In Brief, 433
– OTG, In Brief, 642
– PA32540, In Brief, 920
– Paliperidone palmitate, In Brief, 1012
– Peg-IFN, 166
– Prasugrel, In Brief, 52; 246; 753; 1128; 1223
– Prezista, In Brief, 30
– Promacta, In Brief, 30; 272; FDA panel favors approval, 662; review extended, 752
– PRT-201, In Brief, 1066
– Pulmonary fibrosis drug, In Brief, 614
– Puricase, In Brief, 1129
– Reloxin, In Brief, 614
– Remoxy gets priority review, 946
– Response procedure changes announced at FDA, 801
– Reyataz with Ritonavir, In Brief, 1159
– RG068, In Brief, 459
– Risperdal Consta, In Brief, 459
– Rivaroxaban, In Brief, 892
– Romiplostim, In Brief, 433
– Sabril, In Brief, 246
– Safety

See LEGISLATION, FEDERAL, S 3409

– Seroquel

See SEROQUEL

– Silodosin, In Brief, 220
– Solzira, In Brief, 1064
– Stent system, combination product patent extension opposed (FDA), 1030
– Strattera, In Brief, 588
– Subcutaneous methylnaltrexone, In Brief, 73
– Sugammadex, In Brief, 53
– Surfaxin, FDA seeks more data, 557
– Symbicort, In Brief, 522; 692
– TAK-390MR, In Brief, 53; 1223
– Tapentadol hydrochloride, In Brief, 140
– Telavancin, In Brief, 29
– Tramadol application, more work needed, 775
– TRIUMPH-1, In Brief, 778
– Tropical disease drugs get priority review vouchers, 1215
– Ustekinumab, In Brief, 948
– Valstar maker gets nonapprovable letter from FDA, 27
– Velcade, In Brief, 139
– Zegerid, In Brief, 305
– Zevalin, In Brief, 1098; 1158
– Zingo, In Brief, 642

APPROVALS

– Abilify, In Brief, 272; 588
– Aciphex, In Brief, 778
– Actemra, FDA panel recommends approval, 891
– Alimta, In Brief, 1128
– Allergy drug combination not approvable, 518
– Aloxi, In Brief, 272; 1012
– Alvesco, In Brief, 113
– Amitiza approved for IBS, 520
– Angiomax, In Brief, 642
– Aplenzin, In Brief, 523
– Arcalyst approved, 269
– Asmanex, In Brief, 165
– Avastin

See AVASTIN

– Bazedoxifene, In Brief, 30
– Blood pressure combo drugs, In Brief, 920
– Calcijex, In Brief, 139
– Calcitonin process, In Brief, 113
– Ceftobiprole, In Brief, 335
– Cialis, In Brief, 52
– Cimzia approved for Crohn's disease, 490
– Cinryze, FDA panel recommends approval, 557
– CIP-Tramadol ER, 165
– Clotting solution from recombinant DNA approved, 108
– Colchicine, FDA seeks to stop marketing of unapproved drug, 158
– Concerta, In Brief, 779
– Contrast agents, higher approval standard urged by FDA panel, 745
– Cymbalta, In Brief, 720
– Doribax, FDA panel votes for efficacy and safety of new indications, 861
– Durezol, In Brief, 779
– Edetate disodium injection approval withdrawn, 719
– Emend, In Brief, 139
– Enbrel, new indication urged by FDA panel, 749
– Entereg

See ENTEREG

– Eovist, In Brief, 807
– Evicel, In Brief, 73
– Evolence, In Brief, 778
– Fast-tracking probed by CRS, 241
– Fentora expanded indications rejected by FDA panel, 556
– Fentora, In Brief, 1065
– Fospropofol disodium, FDA panel recommends approval, 584; not approvable, In Brief, 891
– Gamunex approved, 1062
– Gardasil

See GARDASIL

– Glumetza, In Brief, 53
– Hepatitis B test approved, 1039
– Humira, In Brief, 113; new indication, In Brief, 246
– Iloperidone, In Brief, 891; 1066
– Intelence approved for HIV, 109
– Intravenouse, In Brief, 920
– Keppra XR, In Brief, 1065
– Ketek, Grassley (R-Iowa) criticizes FDA approval process, 20
– Kinrix, In Brief, 779
– Kogenate FS, In Brief, 1192
– Luvox CR, In Brief, 30; 166; 273
– Mavik, In Brief, 522
– Mipomersen, In Brief, 523
– MK-0524A not approvable, 518
– Moxatag, In Brief, 139
– Mycamine, In Brief, 140
– Nasacort AQ, In Brief, 1097
– Novolog, In Brief, 335
– NovoSeven Coagulation factor new formulation approved, 586
– Nplate approved, 1009
– Ontak, In Brief, 1223
– OraVerse, In Brief, 587
– Orencia, In Brief, 433
– Oversight of approval process

– – Brown (D-Ohio) seeks probe of fast-track designations, 71
– – Criminals not excluded from FDA review process, House GOP staffers report, 183
– – Grassley (R-Iowa) seeks GAO probe of process, 264

– Pentacel, In Brief, 779
– PrandiMet, In Brief, 779
– Prezista, In Brief, 1222
– Pristiq approved, 268
– ProAir HFA, In Brief, 1097
– RAD001, In Brief, 1042
– Rapaflo, In Brief, 1191
– Reclast, In Brief, 691
– Recothrom thrombin, In Brief, 642
– Relistor approved for opiod-induced constipation, 520
– Requip

See REQUIP

– Romiplostim approval recommended, 301
– Sancuso, In Brief, 1065
– Serdolect, In Brief, 1065
– Simcor, In Brief, 220
– Stavzor, In Brief, 30
– STD drugs, In Brief, 305
– Sugammadex

See SUGAMMADEX

– Surfaxin, In Brief, 667
– Taclonex Scalp, In Brief, 587
– Taranabant, In Brief, 1159
– Teckturna HCT, In Brief, 112
– Tolvaptan, FDA panel favors approval, 775
– Treanda, In Brief, 363
– Treximet, In Brief, 459
– Trivaris, In Brief, 719
– Tysabri approved, 72
– Vaprisol, In Brief, 1221
– Velcade, In Brief, 753
– Vimpat, In Brief, 891
– Voluven approved by FDA, 28
– Vyvanse, In Brief, 491
– Welchol, In Brief, 112
– Xcytrin not approvable, In Brief, 30
– Xenazine approved for Huntington's, 971
– Xyntha approved, 245
– Xyzal, In Brief, 219
– Zyprexa, injection effective for schizophrenia, FDA panel wants warning, 182; non-approvable letter issued, 267

ARANESP

– Anti-anemia drug, Grassley (R-Iowa) seeks information on high rebates, 426
– Pricing claims dismissed (D.N.J.), 955

ARAVA

– Arthritis drug direct purchasers antitrust claim may proceed (S.D.N.Y.), 93; maker accused of filing sham citizen petition with FDA, 1204

ARCALYST

– Chronic inflammatory disease treatment, orphan drug approved, 269

ARGATROBAN

– Anticlotting drug, generic ANDA challenged (S.D.N.Y.), 44

ARICEPT

– Alzheimer's treatment, generic enjoined (D.N.J.), 386
– Approval of generic, In Brief, 73
– Infringement suit against generic maker dismissed for lack of jurisdiction (D.N.J.), 5

ARKANSAS

– Medicaid, state sues Seroquel maker (Ark. Cir. Ct.), 626

ATTORNEYS

– Fees

– – Pricing suit attorney's fee award ruling remanded (7th Cir.), 177
– – Univasc infringement suit, fees denied to defendant (D. Minn.), 39

– Pricing class action, attorney dismissed suit (D. Mass.), 44

AUSTRALIA

– Diabetes studies, Australian findings conflict with U.S. data, 212

AVANDIA

– Clinical trial reports, FDA finds omissions, 429
– Diabetes drug blamed for heart failure and stroke (S.D. Cal.), 17
– Label updated, In Brief, 836
– Securities suit over firm's failure to disclose heart attack risk, claim dismissed (S.D.N.Y.), 604
– Study received by maker before publication, Grassley (R-Iowa) questions, 158

AVASTIN

– Anemia risk, In Brief, 836
– Breast cancer survival studied, In Brief, 220
– Compounding, maker will allow eye doctors to purchase directly from wholesalers, 25

AVINZA

– Painkiller promotional materials ordered pulled, 403

AVODART

– Prostate treatment, infringement alleged (D. Del.), 234

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