Pharmaceutical Law & Industry Report® Index-Summary

SABRIL

– Adult seizure drug approved, 1003
– Epilepsy drug cleared by FDA panel, 73

SAFETY

See also ADVERSE EFFECTS; ADVERSE EVENTS; WARNINGS
– Acetaminophen in prescription drugs, FDA panel urges ban, 802
– Actavis manufacturing, FDA seeks to bar drugmaking at N.J. facility (D.N.J.), 61
– ADHD drugs tied to cardiac deaths, FDA reports, 714
– Asthma drugs and suicidal behavior, FDA continues review, 74
– Biologics plant shutdown, 718; to reopen, 869
– Botox, FDA announces new safety measures, 534; gets boxed warning, 919
– Cambrex Italy facility, FDA finds violations, 1003
– Canadian firms, FDA warns on manufacturing practices, 837
– Caraco drugs seized by FDA, 781
– CellCept

See CELLCEPT

– Cold products may affect sense of smell, FDA says, 718
– Collaboration urged by FDA official, 1079
– Combination drugs, safety rule proposed by FDA, 1173
– Consumer risk-benefit information, simplification sought, 267
– Counties seek reclaimation of drugs by firms, 925
– Digoxin recall, In Brief, 385
– Disposal of drugs, In Brief, 1203
– Duragesic pain patch lots recalled, 46
– Electronic safety reporting mandate proposed by FDA, 998
– Ethex recall expanded, In Brief, 163
– Exjade associated with renal failure, 1145
– Flucloxacillin associated with liver damage, 652
– Foreign drugs

– – Globalization raises issues for FDA, 506
– – India, FDA opens offices, 99
– – Parity in inspections

See LEGISLATION, FEDERAL, HR 759

– – Pilot safety program launched by FDA, 99

– Heparin

See HEPARIN

– Insulin pen sharing, In Brief, 377
– KV stops tablet shipments, 22; suspends manufacturing and shipping of all products, 132; agrees to manufacturing injunction (E.D. Mo.), 251
– Lantus, FDA examines cancer risk, 809
– Liraglutide cancer risk disputed, 414
– Liver injury, FDA issues guidance, 888
– Macroboid recall, In Brief, 541
– Maxipime, no higher mortality risk reported by FDA, 716
– Medicated patches and MRIs, FDA issues warning, 289
– Melamine testing, FDA issues guidance, 949
– Methadone use, In Brief, 510
– Mitigating risk, FDA offers draft guidance for industry, 1141
– Mixed salts recalled, 976
– Mylan W.Va. facility cleared by FDA, 976
– New molecular entities, FDA completes post-marketing safety pilot project, 1232
– Opiods, FDA will require risk evaluation and mitigation strategies, 182; pushed by stakeholders, 644
– Opioids, FDA warns firms marketing unapproved drugs, 1206
– Oversight

– – Communicating risk, panel offers advice for FDA, 532
– – Foreign drugs

See Foreign drugs, this heading

– – Increased FDA inspection resources

See LEGISLATION, FEDERAL, S 882

– – Legal outlook 2009, 79
– – More resources urged for FDA, 102
– – Proprietary drug names, FDA issues review information software, 206
– – Regulatory outlook 2009, 80
– – Risk advisory panel, FDA seeks candidates, 1044
– – Sentinel Initiative at FDA, Senators want updates, 69

– Propafenone HCl recall, In Brief, 352
– Propofol recall, In Brief, 871
– Propoxyphene, FDA panel recommends taking off market, 155
– Proprietary drug name review, FDA plans pilot program, 1141
– Propylthiouacil, liver risk cited, 646
– Ranbaxy plant, FDA says data falsified, 235
– Raptiva

See RAPTIVA

– Relenza, FDA issues warning, 1206
– Resources should be examined by FDA, GAO reports, 861
– Rituxan associated with brain disease, 1261
– Rocephin, FDA revises prescription information, 447
– Sentinel Initiative, FDA plans to open docket, 533
– Seroquel

See SEROQUEL

– Shorter warning letter response times and more inspections predicted, 1000
– Simponi and fungal infections, FDA warns providers, 651
– Skin-numbing products, FDA issues advisory on side effects, 98
– Strategic Plan for Risk Communication issued by FDA, 1142
– Supply chain safety, FDA drafts guidance, 98
– Toll-free number on medication guides, FDA issues guidance, 351
– Transdermal patches recalled, 351
– Trazodone, In Brief, 1208
– Treanda patients, skin reaction reported, 513
– Tysabri, In Brief, 486; 782
– Tysabri, viral infections reported to FDA, 1113
– Ultram ER lots recalled, 47
– Unapproved drugs

– – Narcotics, FDA warns firms to stop making and selling, 381; Lannett to continue marketing, 414; allowed for dying patients, 441
– – Permanent injunction placed on Advent, 447
– – Smuggling unapproved cancer drugs (C.D. Cal.), In Brief, 558

– Vytorin, safety reviewed by FDA, 73
– Wash., tamper-resistant prescription pad bill signed, 593
– Weight loss supplement ingredients, FDA alerts consumers, 18
– Xigris, FDA probes bleeding events and deaths, 160
– Xolair, heart attack and stroke risk examined by FDA, 860
– Zonegran may cause metabolic acidosis, FDA report, 236

SECURITIES

– Adolor shareholder derivative suit dismissed (E.D. Pa.), 615
– Alzheimer's drug, securities fraud class action dismissed (S.D.N.Y.), 369
– Avandia, investors' security fraud suit dismissed (S.D.N.Y.), 992
– Biotechs, fraud class actions “differed dramatically” in 2008, survey finds, 484
– Blood clot drug misstatements, securities fraud class action dismissed (N.D. Cal.), 12
– Blood thinner make accused of misrepresenting safety and prospects, dismissed (2nd Cir.), 770
– Celebrex, investors suit over alleged clinical study misrepresentations timely (3rd Cir.), 150
– Cosmetics firm accused of channel stuffing and failure to disclose acne drug problems (N.D. Cal.), 615
– Derivative suit plaintiffs did not show futility of making pre-suit demand on Pfizer board (2nd Cir.), 120
– Disclosure process and SEC filings, advice offered to firms, 479
– Gilead accused of material misstatements about demand for Viread (U.S., rev den), 464
– Hedge fund advisor settled SEC charges over disclosure and merger, 858
– Merck

– – Employees class action over alleged artificially inflated stock certified (D.N.J.), 361
– – Stock drop claim may proceed (D.N.J.), 368

– Omnicare suit dismissed (6th Cir.), 1254
– Prostate drug, investors accuse maker of false statements (S.D.N.Y.), 259
– Sanofi, rimonabant disclosure suit dismissed (S.D.N.Y.), 1135
– Stiefel accused of undervaluing stock in buy-back scheme (S.D. Fla.), 828
– Tysabari disclosures, In Brief, 1149
– Vioxx maker accused of misrepresenting safety profile and commercial viability (U.S., rev grant), 608; suit improperly reinstated, 993
– Viread maker accused of misrepresenting sales (N.D. Cal.), 679; some shareholder claims may proceed, 1229
– Vytorin

See VYTORIN

SELZENTRY

– HIV drug, FDA panel recommends approval, 1206

SERDOLECT

– Schizophrenia drug, FDA panel favors approval for certain patient populations, 415

SEROQUEL

– Adolescents, FDA panel backs use for mental illnesses, 715
– Antipsychotic diabetes suits

– – Causation, expert witness excluded (Del. Super. Ct.), 734
– – Documents indicate maker suppressed negative trial results and downplayed diabetes risk (M.D. Fla.), 252; evidence of foreign actions excluded, 314
– – Summary judgment granted for maker (M.D. Fla.), 152

– False promotion suit remanded to state court (D.N.M.), 852
– Generic

– – Challenged (D.N.J.), 203
– – Patent upheld (Fed. Cir.), 1127

– Safety

– – FDA panel says drug not safe for all patients, 446
– – New indications raise safety concerns, 269

– Unnecessary prescriptions, health benefit fund cannot recover from maker (M.D. Fla.), 880

SILENOR

– Insomnia drug rejected by FDA, 446

SIMPONI

– Approved for arthritis, 513
– Fungal infections, FDA warns providers, 651

SINGULAIR

– Anticompetitive tactics, class action voluntarily dismissed (D.N.J.), 1099
– Asthma drug and suicidal behavior, FDA continues review, 74
– Generic blocked (D.N.J.), 961

SKELAXIN

– Muscle relaxant method patents invalid (E.D.N.Y.), 92

SOLODYN

– Acne drug generic patent dispute settled (D. Del.), 337; consent agreement entered, 992
– Proposed generic, infringement alleged (D. Del.), 705

SOTRADECOL

– Varicose vein treatment, FDA says web pages are misleading, 1109

SOUTH CAROLINA

– Zyprexa, Atty. Gen. settles fraudulent marketing suit (S.C. Cir. Ct.), 1249

STALEVO

– Parkinson's drug infringement claims settled (D. Del.), 526

STATUTES OF LIMITATIONS

– Neo-Synephrine addiction, suit time-barred (N.D. Ill.), 177
– Taiwanese hemophiliacs claims against blood concentrate makers time-barred (N.D. Ill.), 466

STELARA

– Psoriasis drug approved, 1146

STEM CELL RESEARCH

– ALS trial, In Brief, 26
– License agreement, In Brief, 541
– Osiris and FDA, In Brief, 104

STRATTERA

– ADHD drug direct infringement claim dismissed (D.N.J.), 609

SULINDAC

– Anti-inflammatory drug blamed for SJS, federal law no bar to suit (D.N.H.), 1190

SUPREME COURT, U.S.

– False Claims Act public disclosure jurisdiction limited (rev grant), 729
– Generic drugs

– – Lexapro, declaratory judgment against generic maker dismissed (rev den), 227
– – Prilosec, generic infringed valid patent (U.S., rev sought), 147; (rev den), 282
– – Risperdal, jurisdiction lacking to hear patent counterclaims (rev den), 340

– N.H. ban on prescription data sales upheld (rev sought), 363; other states await ruling, 544; (rev den), 763
– Patents

– – Actos patent dispute, attorneys' fees upheld (rev den), 1166
– – Acular patent upheld (rev den), 117
– – Cipro settlement challenged (rev den), 730
– – Generic drugs

See Generic drugs, this heading

– – Lovenox patent not enforceable (rev sought), 171; (rev den), 495
– – “Machine or transformation” test questioned (briefs filed), 939

– Plavix

– – Active ingredient, patent not invalid for anticipation or obviousness (rev sought), 912

– Product liability

– – Antidepressants, failure-to-warn of suicide risk, preemption ruling remanded (dec), 280
– – Phenergan blamed for gangrene and loss of guitar player's arm, failure to warn claim not preempted (dec), 249; Analysis & Perspective, 353; preemption limits, Analysis & Perspective, 388; discussed at conference, 564; effect on preemption defense, Analysis & Perspective, 658

– Provenge, politically-motivated delay in approval alleged, dismissal affirmed (rev den), 61
– Securities, Gilead accused of material misstatements about demand for Viread (rev den), 464
– Trovan clinical trials, maker accused of violating international norms (rev sought), 854
– Vioxx maker accused of misrepresenting safety profile and commercial viability (rev grant), 608; suit improperly reinstated (dec), 993

SURFAXIN

– Respiratory distress syndrome drug application, FDA wants more data, 477

SWINE FLU

See H1N1 VIRUS

SWINE FLU OUTBREAK

See INFLUENZA

SWITZERLAND

– Erectile dysfunction drugs, price-fixing alleged, 214