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OFF-LABEL USE

– Actimmune

See ACTIMMUNE

– Aranesp class action dismissed (C.D. Cal.), 730
– Bextra marketing, ex-sales manager pleads guilty (D. Mass.), 370; sentenced, 736
– Botox maker seeks to block FDA enforcement (D.D.C.), 1163
– Cancer drug studies vary in quality, 1258
– Cephalon class action dismissed (D.N.J.), 1196
– Destruction of documents, ex-manager convicted of obstruction of justice (D. Mass.), 316; sentenced, 885
– Enforcement, increased scrutiny predicted, Special Report, 420
– False claims

See FALSE CLAIMS

– Forest Labs settles false claims (D. Mass.), 1166
– Guidance on promotion offered by legal experts, 745
– Lovenox qui tam suit may proceed (N.D. Ill.), 501
– Medicare

– – Coverage conditions more complex for drugs than devices, 382
– – State Attys. Gen. support CMS proposal to block insurers' requirement, 345

– Neurotonin

See NEUROTONIN

– Pediatric products, Special Report, 572
– Regulatory outlook 2009, 80
– “Reprint practices,” FDA issues guidance, 65
– RICO

See RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS (RICO) ACT

– RU-486, prescribing for off-label use banned (Ohio), 794; remanded (6th Cir.), 943
– Schering illegal marketing allegations dismissed (D.N.J.), 855
– Zyprexa marketing

See ZYPREXA

OHIO

– RU-486, prescribing for off-label use banned (Ohio), 794; remanded (6th Cir.), 943

OMNICEF

– Antibiotic, generic created by different process no infringement (Fed. Cir.), 605

ONGLYZA

– Diabetes drug approved by FDA, 922
– Diabetes drug, FDA panel favors approval, 414; application, timeline extended, 513

ONSOLSIS

– Cancer drug approved, 867

OPANA ER

– Painkiller, patent infringement suit over generic dismissed (D.N.J.), 230

OREGON

– Adverse event reporting system, few pharmacies participating, 950

ORGAN TRANSPLANTS

– Anti-rejection drug copy, FDA may approve (D.D.C.), 967
– Generic immunosuppressants, FDA denies petition to additional measures to protect transplant recipients, 951
– TOL101, In Brief, 451

ORLISTAT

– Obesity drug and liver injury, FDA reviews adverse events, 1002

ORPHAN DRUGS

– DNage BV, In Brief, 515
– Grant program planned by FDA for clinical trials, 18
– HPN-100, In Brief, 18; designation received, 541
– KRX-0401, In Brief, 1084
– Oxycyte, In Brief, 571
– Paclical, In Brief, 451
– Qutenza, In Brief, 656
– Restanza, In Brief, 1084
– RiaSTAP approved for bleeding in patients with congenital fibrinogen deficiency, 102; approved, In Brief, 299
– TOL101, In Brief, 451

ORTHO TRI-CYCLEN

– Contraceptive maker challenges generic (D.N.J.), 733; generic maker halts shipments, 836; settled, 879

OVCON

– Chewable contraceptive formulation, antitrust settlement reached (D.D.C.), 12

OXYCONTIN

– Misbranding, Purdue Frederick ex-execs barred from federal programs, 119

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