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GABITRIL

– Epilepsy drug off-label marketing, dismissal denied (E.D. Pa.), 996

GARDASIL

– Cervical cancer vaccine broader use, FDA seeks more data, 73; new indication approved, 1234
– Male use urged by CDC panel, 1261

GEMZER

– Cancer drug, method-of-use patent invalid (E.D. Mich.), 962

GENERIC DRUGS

– Accutane discontinued due to generic competition, 780
– Affordable generics

See LEGISLATION, FEDERAL, S 369

– Ala. Atty. Gen. seeks to dismiss suits against pharmacies for deceptive trade practices, 1204
– ANDAs

See ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)

– Anti-rejection drug copy, FDA may approve (D.D.C.), 967
– Applications

– – Backlog, FDA to address, 1077
– – Copaxone, In Brief, 1085
– – Duac, In Brief, 1116

– Approvals

– – Accuretic, In Brief, 298
– – Alkeran, In Brief, 691
– – Altace, In Brief, 298
– – Antizol, In Brief, 1150
– – Atripla, In Brief, 977
– – Biotech drugs

See LEGISLATION, FEDERAL, HR 1427

– – Casodex, In Brief, 810
– – Catapres TTS, In Brief, 977
– – CellCept, In Brief, 571
– – Cytomel, In Brief, 871
– – Depakote ER, In Brief, 953
– – Depakote, In Brief, 164
– – Eloxatin, In Brief, 952; approval suspended, 963; reinstated, 1001
– – Flomax, In Brief, 1178
– – Haldol, In Brief, 871
– – Idamycin, In Brief, 952
– – Imitrex

– – – Mylan, In Brief, 952
– – – Raxbaxy, In Brief, 952

– – Kaletra, In Brief, 324
– – Keppra, In Brief, 104
– – Klaron, In Brief, 386
– – Lamictal, In Brief, 133
– – Lithium carbonate, In Brief, 192
– – Mircette, In Brief, 50; 51
– – Plan B, generic by Duramed approved, 741; Watson generic approved, 1055
– – Precose, In Brief, 627
– – Prilosec, In Brief, 134
– – Restoril, In Brief, 720
– – Roxicodone, In Brief, 451
– – Sinemet, In Brief, 1149
– – Singulair, In Brief, 656
– – Starlix, In Brief, 1085
– – Sun Pharma, In Brief, 49
– – Tegretol-XR, In Brief, 418
– – Toprol XL, In Brief, 927
– – Zerit, In Brief, 51
– – Zithromax, In Brief, 385; 782
– – Zosyn, generic approval challenged (D.D.C.), 1099

– Aurobindo, In Brief, 272
– Authorized generics

– – Ban on sales by brand-name maker, 265
– – Information submission, FDA withdraws rule, 181; final rule issued, 886
– – Listing from FDA urged by senators, 206
– – Marketing ban

See LEGISLATION, FEDERAL, HR 380

– BCBS, community-based programs expanding use, 450
– BenzaClin, In Brief, 1056
– Biogenerics

See BIOGENERICS

– Biologics, In Brief, 782
– Biosimilars

See LEGISLATION, FEDERAL, HR 1548

– Biotech drugs

See LEGISLATION, FEDERAL, S 726

– Budget for FDA includes pathway for generic biotech drugs, 260
– Caraco drugs seized by FDA, 781
– Delaying release

See LEGISLATION, FEDERAL, HR 1706

– Delays

See LEGISLATION, FEDERAL, S 1778

– Digoxin, In Brief, 418
– Doryx

See DORYX

– Duac maker claims infringement (D. Del.), 640
– Effexor

See EFFEXOR

– Efudez, investment firm accused of giving trade secrets to competitor (D. Del.), 523
– Ellence, In Brief, 926
– Enablex, In Brief, 515
– EU, action urged to prevent seizures of drug shipments, 240
– Evista

See EVISTA

– Evoclin, In Brief, 324
– “Facts and myths,” at FDA website, In Brief, 806
– Flomax copy planned (N.D. Cal.), 1195
– Flonaise, In Brief, 325
– Fludara, In Brief, 926
– Fortical generic blocked (S.D.N.Y.), 1028
– Imitrex, In Brief, 237
– Immunosuppressants, FDA denies petition to additional measures to protect transplant recipients, 951
– Japan, manufacturing allowed before patent expiration, 487
– Levitra generic challenged (D. Del.), 798
– Lexapro, declaratory judgment against generic maker dismissed (U.S., rev den), 227
– Medicaid

See MEDICAID

– Medicare

See MEDICARE DRUG COVERAGE

– Metoclopramide, brand name maker liable for neurological condition blamed on generic (Cal.), 117
– Miacalcin, In Brief, 691
– Minn. pricing law, union funds sue pharmacy chains (D. Minn.), 1029
– Naropin, generic blocked (D.N.J.), 907; appealed, 1035
– N.Y., generic use down upstate, 209
– Patents

– – Actonel

See ACTONEL

– – Adderall XR, generic maker to get license (D. Colo.), 1195
– – Allegra

See ALLEGRA

– – Alphagan, generic infringes patent (D. Del.), 1248
– – Aricept infringement alleged, inequitable conduct defense permitted (D.N.J.), 796
– – Avinza, infringement alleged over ANDA (D.N.J.), 1071
– – Carbatrol generic challenge settled (S.D.N.Y.), 1100
– – Clarinex, generic permitted (D.N.J.), 943
– – Clarinex suit settled (D.N.J.), 437
– – Codexis biocatalyst, In Brief, 49
– – Combigan generic challenged (E.D. Tex.), 438
– – Concerta, generic no infringement (D. Del.), 364
– – Contan and Stalevo, infringement claims settled (D. Del.), 526
– – Eloxatin

See ELOXATIN

– – Emend, generic plans challenged (D.N.J.), 284
– – Ethyol dispute settled (D. Md.), 910
– – Evoclin maker seeks to block generic (D. Del.), 335
– – Exclusivity

See LEGISLATION, FEDERAL, S 1315

– – Femcon Fe settlement (D.N.J.), In Brief, 15
– – Fentora, infringement claim over generic may proceed (D. Del.), 436
– – Ferrlecit license, In Brief, 896
– – Fosrenol maker seeks to block generic (S.D.N.Y.), 405
– – Loestrin 24, generic sales opposed (D. Del.), 1068
– – Mucinex D generic ANDA challenged by patent holder, 690
– – Namenda generic challenge, some firms dismissed (D. Del.), 1100
– – Omnicef, generic created by different process no infringement (Fed. Cir.), 605
– – Opana ER, infringement suit over generic dismissed (D.N.J.), 230
– – Ortho Tri-Cyclen maker challenges generic (D.N.J.), 733; generic maker halts shipments, 836; settled, 879
– – Patanol, infringement alleged (S.D. Ind.), 202
– – Pfizer Indian licenses announced, 624
– – Prandin patent validity, summary judgment denied (E.D. Mich.), 733
– – Pulmicort maker seeks to block generic (D.N.J.), 436; blocked, 461; preliminary injunction, 610
– – Seroquel generic challenged (D.N.J.), 203
– – Strattera drug direct infringement claim dismissed (D.N.J.), 609
– – Valcyte patent valid, generic does not infringe (D.N.J.), 1189; appealed, 1251
– – Vanos infringement dispute settled (W.D. Mich.), 463
– – Vfend, In Brief, 1238

– Paxil, supply and license contract dispute, $70M awarded for breach (N.D. Ill.), 201
– Prices lower when “authorized generics” marketed, FTC reports, 737
– Prilosec, generic did not infringe (S.D.N.Y.), 309
– Protonix, generic advertising challenged (E.D. Mich.), 554
– Reglan blamed for movement disorder, failure-to-warn claim against generic maker not preempted (D. Vt.), 6; review denied, 465
– Reverse payment deals targeted by FTC, 372
– Risk Evaluation and Mitigation Studies, FDA urged to prevent firms from blocking generics, 780
– Risperdal

See RISPERDAL

– Rocaltrol, In Brief, 1054
– Singulair generic blocked (D.N.J.), 961
– Solodyn

See SOLODYN

– Tindamax, In Brief, 163
– Topamax

See TOPAMAX

– Tricor, consumer suit over generic delay, settlement approved (D. Del.), 500
– Vancocin, FDA panel approves testing guidelines, 922
– Wellbutrin, generic makers accused of making inferior product (Cal. Super. Ct.), 706
– Xeloda, generic challenged (D.N.J.), 438
– Xopenex, dispute over generic settled (D. Del.), 286
– Xyzal

See XYZAL

– Zofran, In Brief, 926

GENETICS AND BIOTECHNOLOGY

– Biogenerics, AARP supports, 624
– Biologics

See BIOLOGICS

– Biosimilars

See LEGISLATION, FEDERAL, HR 1548

– Data exclusivity, biotech industry seeks 14 years, 131
– Generic drugs

See LEGISLATION, FEDERAL, S 726

– Health reform, biosimiliars pathways sought by governors, 1142
– Long exclusivity period pushed at conference, 622
– Personalized medicine

See PERSONALIZED MEDICINE

– Securities fraud class actions “differed dramatically” in 2008, survey finds, 484
– Unpatentable law of nature, gene expression at issue (Fed. Cir.), 172; rehearing granted, 988

GEODON

– Adolescents, FDA panel backs use for mental illnesses, 715

GEORGIA

– Product liability, governor proposes protection for drug and device makers, 209

GLEEVEC

– Gastrointestinal cancer drug approved, 23

GRANTS

– Schizophrenia drug funding, In Brief, 133

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