Pharmaceutical Law & Industry Report® Index-Summary

LABELS AND PACKAGING

See also SAFETY; WARNINGS
– Arava and liver damage, 928
– Avastin and breast cancer, 1590
– Cal., larger type sought, 788
– Clinical efficacy, labels and ads, 1558
– Colcrys dosing, 632
– Diabetes drugs, MDs' group sues FDA (D.D.C.), 916
– Draft guidance from FDA, 859; final rules, 1625
– EU rules, 1530
– Gadolinium-based contrast agents, 1188
– Gianvi label corrections (N.D. Ill.), 814
– Hypertension indication, FDA proposed guidance, 392
– Invirase and heart risk, 1376
– LABAs and asthma, 752
– Lamisil and skin disease (D.N.J.), 1218
– Motrin labeling, preemption of Tex. law (N.D. Tex.), 157
– Off-label use

See OFF-LABEL USE

– Ortho-Evra patch labeling (N.D. Ohio), 160
– Osteoporosis drugs updated labels, 1314
– Plavix boxed warning, 367
– Propylthiouracil boxed warning, 566
– Regulatory agenda for FDA, 592
– Standardization proposal, 632
– Tysabri, 1636
– Velcade, 45
– Vivitrol, 600
– WinRho SDF boxed warning, 371
– Workshop at FDA, 494

LAMISIL

– Anti-fungal drug and skin disease (D.N.J.), 1218

LATANOPROST

– Glaucoma drug, Italian antitrust probe, 1479

LATUDA

– Schizophrenia drug approval, 1410

LAVIV

– Wrinkle treatment application, 23

LEGISLATION, FEDERAL

– House

– – HR 628, Patent expertise at district courts, 1628
– – HR 1586, Increased Medicaid matching funds, 1028
– – HR 3590, Patient Protection and Affordable Health Act, Democratic reform bill Senate passage, 17; Medicaid reimbursement, 18; pay-for-delay proposal, 42; implementation issues, 390; signed, 425; key provisions, Special Report, 435
– – HR 3962, Affordable Health Care for America Act, pay-for-delay proposal, 42
– – HR 4213, American Jobs and Closing Tax Loopholes Act, Rangel, Medicaid matching funds, 684
– – HR 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act, Lynch, addresses prices, 249; House panel approves, 424
– – HR 4732, Compassionate Access Act, Watson, would ease access to investigational products, 329
– – HR 4816, FDA Administration Improvement Act, Hinchey, would overhaul agency, 361
– – HR 4872, Health Care and Education Reconciliation Act, Medicaid rebates, signed, 423; key provisions, Special Report, 435
– – HR 4899, Supplemental Appropriations Act, 2010, would bar patent settlements that delay generics market entry, House approval, 893
– – HR 4994, Medicare and Medicaid Extenders Act, restoring children's hospital drug discounts, 1586
– – HR 5712, Veterans', Seniors', and Children's Health Technical Corrections Act, Medicare/Medicaid/CHIP technical corrections, 926
– – HR 5732, Medicare off-label coverage, Kilroy, 955
– – HR 5740, FDA mandatory recall of adulterated or misbranded drugs, Towns, 953

– Senate

– – S 2942, Nanotechnology Safety Act, Prior and Cardin, would establish FDA program, 212
– – S 3000, Federal Medical Assistance Percentage increase, Rockefeller, 216
– – S 3606, FDA FY2011 funding, 952
– – S 3653, Health Care Bureaucrats Elimination Act, would end payment advisory board, 1029
– – S 3690, Drug Safety and Accountability Act, Bennet, would increase FDA enforcement power, 1025

LEVAQUIN

– Antibiotic and tendon toxicity, no consolidation (D. Minn.), 36; no summary judgment, 1021
– Labeling, petitions admissible (D. Minn), 1505; failure to warn, $1.7M award, 1582
– Patent extension (Fed. Cir.), 617; BNA Insights, 762; rehearing denied, 976

LIALDA

– Ulcerative colitis drug infringement alleged (D. Del.), 947

LIPITOR

– Brazilian patent expiration, 1163
– Cholesterol drug marketing qui tam action (E.D.N.Y.), 208; no DOJ intervention, 1247
– Discovery compelled (N.D. Ill.), 1085
– Infringement, transfer request denial (Fed. Cir.), 181
– Philippines, generic retail sales, 221; reconsideration sought, 258
– Recall, 1414; another lot recalled, 1635

LOBBYING

– PhRMA chief's departure, 215; new CEO, 928; chairman named, 1563

LORCASERIN

– Weight-loss drug application, 24; goal review date, 294; more data sought, 1378; resubmission, 1632

LOUISIANA

– Medicaid overcharges (La. Dist. Ct.), 1430
– Zyprexa off-label use settlement (E.D.N.Y.), 488

LOVENOX

– Generic

– – Anticoagulant generic announced, 995
– – Blood-thinning drug, generic approval challenge (D.D.C.), 975; no withdrawal, 1138
– – Challenged (D. Mass.), 1550

– Raw material sought (D.D.C.), 1396; released by FDA, 1459

LUCOX CR

– OCD drug generic settlement (D. Del.), 1141

LUMIGAN

– Elevated Intraocular pressure drug promotion, 1563

LUMIZYME

– Pompe disease drug approval, 688

LUNESTA

– Approval of generic, 401
– Sleeping pill generic inequitable conduct claims (D.N.J.), 774; settled, 1054

LUVAX

– Anxiety drug patient brochure, FDA warning letter, 962

LYRICA

– Anxiety disorder drug application, 23