NEW DRUGS 1999-2000

Generic Name

Trade Name

Company

Approval

Year

Pharm/Chem Class

Therapeutic

Indication(s)

Alitretinoin

Panretin

Ligand

P/NME

1999

Retinoid

AIDS-Kaposi

AIDS-related Kaposi's sarcoma

Alosetron

Lotronex

Glaxo Wellcome

 

2000

5-HT3 antagonist

IBS

IBS

Aminolevulinic acid HCl

Levulan Kerastick

Guidelines

NME

1999

protoporphyrin IX Precursor

Cancer

precancerous skin lesions

Amprenavir

Agenerase

Glaxo Wellcome

P(6)/NME

1999

Proteus Inhibitor

AIDS

HIV virus and AIDS

Articaine HCl

Septocaine

Deproco

 

2000

Anilide Anesthetic?

Local Anesthetic

Not used in US?!?!?

Aspirin/Dipyridamole

Aggrenox

Boehringer-Ingelheim

P/Combination

1999

NSAID/

Stroke

reduction of the risk of stroke

Bexarotene

Targretin

Ligand

NME/Orphan

1999

Retinoid

Cancer

Cancer-CTLC

BCG, Live

Pacis

BioChem Pharma

 

2000

Bacillus Calmette-Guerin

Cancer

prostate and bladder cancer

Busulfan

Busulfex

Orphan Med

P

1999

Alkylator

Cancer

bone marrow transplantation,

Caffeine citrate

Cafcit

Oread Pediatric

P/Combination

1999

Xanthine

Respiratory

apnea of prematurity

Cevimeline HCl

Evoxac

Snowbrand

 

2000

Muscarinic Agonist

Sjogren's Syndrome

Improve Dry mouth

Cilostazol

Pletal

Otsuka Pharm

NME

1999

PDE Inhibitor/Quinolinone

Intermittent Claudication

 

Colesevelam HCl

Welchol

Gel Tex

NME

2000

GI sequestrant

Hypolipidemic

elevated LDL-C with statin

Cytarabine liposome

Depocyt

Depotech

P

1999

Nucleoside Antimetabolite

Cancer

neoplastic meningitis

Dalfopristin/Quinupristin

Synercid

Rhone-Poulenc Rorer

P/NME

1999

Streptogramin

Infection

VRE-faecium

Denileukin diftitox

Ontak

Seragen

Orphan

1999

diphtheria toxin to interleukin-2 (IL-2)

Cancer

Cancer-CTLC

Dexmedetomidine HCl

Precedex

Abbott

NME

1999

Alpha-2 Agonist

Sedation

Intubated/mechanically ventilated Pts

Dofetilide

Tikosyn

Pfizer

NME

1999

Class III

Arrhythmias

Convert Afib/Aflut to normal sinus rhythm

Doxercalciferol

Hectorol

Bone Care

NME

1999

Vitamin D

Secondary hyperparathyroidism (dialysis)

Secondary hyperparathyroidism (dialysis)

Entacapone

Comtan

Orion/Novartis

NME

1999

COMT Inhibitor

Parkinsonism

Adjunct with L-DOPA/carbidopa

Epirubicin HCl

Ellence

Pharmacia&Upjohn

P/NME/Orphan

1999

Anthracycline

Cancer

Breast cancer: Axillary node tumor involvement post resection

Estradiol/Norethindrone Acetate

Activella

Pharmacia

 

2000

Hormones

Osteoporosis

Postmenopausal Osteoporosis

Etanercept

Enbrel

Immunex Wyeth-Ayerst

Orphan

1999

TNF-IGG-1 Complex

Arthritis

polyarticular course juvenile rheumatoid arthritis

Exemestane

Aromasin

Pharmacia&Upjohn

NME

1999

Aromatase Inhibitor

Cancer

advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Gadoversetamide

Optimark

Mallinckrodt

NME

1999

 

Imaging

 

Ganirelix acetate

Antagon

Organon

P(6)/NME

1999

GnRH Antagonist.

Infertility

Inhibitor of premature ovulation: Fertility testing

Gatifloxacin

Tequin

Bristol-Myers Squibb

NME

1999

Fluoroquinolone

Infection

Oral/IV: Respiratory/GU infections

Gemtuzumab ozogamicin

Mylotarg

Wyeth-Ayerst

Biologic

2000

Monoclonal antibody

Cancer

CD33+ acute myeloid leukemia (AML)

Human Insulin

Velosulin

Novo Nordisk

 

1999

Insulin

Diabetes

 

Infliximab

Remicade

Centocor

 

1999

monoclonal antibody

Arthritis

with methotrexate for the treatment of patients with rheumatoid arthritis

Insulin glargine

Lantus

Aventis

 

2000

Insulin Analogue

Diabetes

Type I Diabetes

Ketotifen fumarate

Zaditor

Ciba Vision

P(6)/NME

1999

Histamine-1 antagonist

Conjunctivitis

Allergic disease

Levetiracetam

Keppra

UCB Pharm

NME

1999

Mech Unknown

Epilepsy

partial onset seizures

Levobupivacaine

Chirocaine

Darwin Disc

P/Combination

1999

Anesthesia/Pain

 

 

Levonorgestrel

Plan B

Womens Capital

P

1999

synthetic progestin

Contraception

 

Linezolid

Zyvox

Pharmacia&Upjohn

 

2000

oxazolidinone

Infection

Enterococcal (VRE) and Staph infections

Meloxicam

Mobic

Boehringer-Ingelheim

 

2000

NSAID/Oxicam

Arthritis

Osteoarthritis

Mequinol/Tretinoin

Solage

Bristol-Myers Squibb

NME

1999

Hydroquinone/Retinoid

Dermatologic

Solar lentigines ("Liver spots")

Moxifloxacin HCl

Avelox

Bayer

NME

1999

Fluoroquinolone

Infection

Respiratory infections

Nedocromil sodium

Alocril

Allergan

P

1999

Cromolyn Analog

Asthma

 

Nitric oxide

INOmax

INO Therapeutics

P/NME

1999

Nitric Oxide

Hypertension

persistent pulmonary hypertension in the newborn

Orlistat

Xenical

Roche

P/NME

1999

Lipase inhibitor

Obesity

Obesity

Oseltamivir phosphate

Tamiflu

Roche

P(6)/NME

1999

Neuraminidase Inhibitor

Influenza

onset of influenza A and B

Oxcarbazepine

Trileptal

Novartis

 

2000

Carbamazepine Analog

Epilepsy

partial onset seizures

Pantoprazole

Protonix

Wyeth-Ayerst

 

2000

Proton Pump Inhibitor

GERD

Erosive Esophagitis assocaited with GERD

Pemirolast potassium

Alamast

Santen

P(6)/NME

1999

Cromolyn Analog

Conjunctivitis

Allergic disease

Pioglitazone HCl

Actos

Eli Lilly

P(6)/NME

1999

thiazolidinedione

Diabetes II

type II

Pneumococcal Vaccine

Prevnar

Wyeth-Ayerst

 

2000

Vaccine

Infection

prevent invasive pneumococcal diseases in

Poractant alfa

Curosurf

Deys Labs

NME

1999

lung surfactant

Respiratory

infants and toddlers

Rabeprazole sodium

Aciphex

Eisai

NME

1999

Proton Pump Inhibitor

Ulcers

Duodenal Ulcers

Rapacuronium bromide

Raplon

Organon

NME

1999

NMBA

Adjunct in surgery

Adjunct in surgery

Rivastigmine tartrate

Exelon

Novartis

 

2000

ACHE Inhibitor

Alzheimer's disease

Alzheimer's disease

Rofecoxib

Vioxx

Merck

P(6)/NME

1999

COX-2 Inhibitor

Arthritis

ostearthritis, menstrual pain and the management of acute pain in adults

Rosiglitazone maleate

Avandia

SKBeecham

P(6)/NME

1999

thiazolidinedione

Diabetes II

type II

Sirolimus

Rapamune

Wyeth-Ayerst

P/NME

1999

Immunosuppresant

immunosuppressant

prophylaxis: Organ rejection (Renal transplants)

Sodium ferric gluconate

Ferrlecit

R&D Labs

P/NME

1999

Iron

Iron Deficiency

Pts undergoing chronic dialysis

Somatropin (rDNA origin)

Nutropin Depot

Genentech

P

1999

recombinant growth hormone

Growth

long-term treatment of growth failure

Technetium depreotide

Neotect

Diatide

P/NME

1999

 

Imaging

 

Temozolomide

Temodar

Schering

P/NME/Orphan

1999

Imidazotetrazine Alkylator

Cancer

anaplastic astrocytoma (brain cancer)

Tenecteplase

TNKase

Genentech

Biologic

2000

Enzyme

Thrombolytic

AMI

testosterone gel

AndroGel

Unimed Pharm

 

2000

Steroid: Androgen

Steroid: Androgen

hypogonadism

Verteporfin

Visudyne

QLT Photother

 

2000

 

 

age-related macular degeneration

Zaleplon

Sonata

Wyeth-Ayerst

NME

1999

Pyrazolopyrimidine

Insomnia

GABA-A ligand:

Zanamivir

Relenza

Glaxo Wellcome

P/NME

1999

Neuraminidase Inhibitor

Influenza

influenza

Zonisamide

Zonegran

Elan Pharm

 

2000

"Valphenytoin"

Epilepsy

partial onset seizures