Pharmaceutical Law & Industry Report® Index-Summary

OCTAGAM

– Primary humoral immuniodeficiency drug recall, 1259

OFF-LABEL USE

– Actimmune, proof of damages (N.D. Cal.), 1462; DOJ memo, 1616
– Aransep suit dismissal (9th Cir.), 1363
– FDA limits challenge (D.D.C.), 519
– Kaletra kickback claims (D. Mass.), 943
– Kos settlement (M.D. La.), 1550
– Marinol promotion (U.S., rev den), 815
– Medicare

See LEGISLATION, FEDERAL, HR 5732

– Neurontin promotion, jury verdict (D. Mass.), 416; Cal. sales, 1426
– Pfizer consumer fraud suit (E.D. Pa.), 988
– Rapamune whistleblower suit (E.D. Pa.), 715; DOJ intervention, 1209
– Rituxan, whistleblower (E.D. Pa.), 778
– Topamax settlement, 584
– Trilepatl cases, 1269
– Zyprexa, La. settlement (E.D.N.Y.), 488

OMAPRO

– Cancer drug application, 397

OMNICEF

– Antibiotic, no patent infringement (U.S., rev den), 59

OPANA ER

– Barr Labs, painkiller generic infringement settlement (D.N.J.), 516
– Impax and Sardoz generic infringement settlements (D.N.J.), 746

ORACEA

– Rosacea generic blocked, 887

ORAL COLCHICINE

– Gout drug unapproved uses (D.N.J.), 1397

ORAPED ODT

– Corticosteroid generic infringement claim (D. Del.), 1620

OREGON

– Psychologists prescription authority, 330; vetoed, 498

ORPHAN DRUGS

– AEZA-108, 634
– Alpha1-Proteinase Inhibitor, 191
– AP24534, 294
– BMN-701, 1161
– Carbaglu approved, 398
– Ciprofloxacin status, 368
– CK-2017357, 371
– Collaboration, FDA and EU, 285
– ENMD-2076, 218
– FDA workshop, 20
– Graspa, 173
– IMGN901, 335; 1122
– LRX-0401, 966
– MP4CO, 1476
– Nefecon, 1325
– Octreolin, 868
– QPI-1002, 218
– RG2833, 692
– Sapacitabine, 902
– SBC-102, 932
– TOL101, 827
– TXA127, 868
– Workshop, FDA plans, 1316
– Xifaxan for hepatic encephalopathy, 291

OXYCONTIN

– False claims dismissal (4th Cir.), 417; (U.S., rev den), 1304
– Product liability, out-of-state claims (N.Y. Sup. Ct.), 1278