Tables

Table 1. New Therapeutic Agents Marketed in the United States in 2003

Generic Name Trade Name Manufacturer Therapeutic Classification Route of Administration FDA Classification^a JAPhA Page No. Where Coverage Begins
Adalimumab^b Humira Abbott Antiarthritic agent Subcutaneous S^c 184
Agalsidase beta Fabrazyme Genzyme Agent for Fabry disease Intravenous P, H, V^c 202
Alefacept Amevive Biogen Agent for psoriasis Intramuscular S^b 186
Alfuzosin hydrochloride Uroxatral Sanofi-Synthélabo Agent for benign prostatic hyperplasia Oral 1-S 191
Aprepitant Emend Merck Antiemetic agent Oral 1-P 189
Atazanavir sulfate Reyataz Bristol-Myers Squibb Antiviral agent Oral 1-P 172
Atomoxetine hydrochloride^b Strattera Lilly Agent for attention deficit hyperactivity disorder Oral 1-S 180
Bortezomib Velcade Millennium Antineoplastic agent Intravenous 1-P, H 197
Daptomycin Cubicin Cubist Antibiotic Intravenous 1-P 169
Efalizumab Raptiva Genentech; Xoma Agent for psoriasis Subcutaneous S^c 186
Eletriptan hydrobromide^b Relpax Pfizer Agent for migraine Oral 1-S 182
Emtricitabine Emtriva Gilead Sciences Antiviral agent Oral 1-S 172
Enfuvirtide Fuzeon Roche; Trimeris Antiviral agent Subcutaneous 1-P, H 172
Eplerenone^c Inspra Pfizer Agent for congestive heart failure and hypertension Oral 1-S 177
Gefitinib Iressa AstraZeneca Antineoplastic agent Oral 1-P, H 196
Icodextrin^b Extraneal Baxter Agent for peritoneal dialysis Peritoneal 1-S 204
Laronidase Aldurazyme Genzyme Agent for mucopolysaccharidosis Intravenous P, V^c 201
Memantine hydrochloride Namenda Forest Agent for Alzheimer's disease Oral 1-S, V 182
Mequinol/tretinoin^b Solagé Galderma Depigmenting agent Topical 1, 4-S 200
Miglustat Zavesca Actelion Agent for Gaucher disease Oral 1-S, V 203
Nitazoxanide^b Alinia Romark Antiparasitic agent Oral 1-P, V 176
Omalizumab Xolair Genentech; Novartis Antiasthmatic agent Subcutaneous S^c 188
Palonosetron hydrochloride Aloxi MGI Pharma Antiemetic agent Intravenous 1-S 190
Pegvisomant Somavert Pfizer Agent for acromegaly Subcutaneous 1-P, V 195
Rosuvastatin calcium Crestor AstraZeneca Antihyperlipidemic agent Oral 1-S 178
Tadalafil Cialis Lilly; ICOS Agent for erectile dysfunction Oral 1-S 192
Tositumomab and iodine I-131 tositumomab Bexxar Corixa; GlaxoSmithKline Antihyperlipidemic agent Intravenous P^c 198
Vardenafil hydrochloride Levitra Bayer; GlaxoSmithKline Agent for erectile dysfunction Oral 1-S 192

a FDA classification of new drugs: 1 = new molecular entity; 4 = combination product; P = priority review; S = standard review; H = accelerated approval; V = designated orphan drug.
b Approved by FDA before 2003 but not marketed until 2003.
c A biological approved through an FDA procedure that does not assign a numerical classification.

Generic Name	Trade Name	Manufacturer	Therapeutic Classification	Route of Administration	FDA Classification^a	JAPhA Page No. Where Coverage Begins
Adalimumab^b	Humira	Abbott	Antiarthritic agent	Subcutaneous	S^c	184
Agalsidase beta	Fabrazyme	Genzyme	Agent for Fabry disease	Intravenous	P, H, V^c	202
Alefacept	Amevive	Biogen	Agent for psoriasis	Intramuscular	S^b	186
Alfuzosin hydrochloride	Uroxatral	Sanofi-Synthélabo	Agent for benign prostatic hyperplasia	Oral	1-S	191
Aprepitant	Emend	Merck	Antiemetic agent	Oral	1-P	189
Atazanavir sulfate	Reyataz	Bristol-Myers Squibb	Antiviral agent	Oral	1-P	172
Atomoxetine hydrochloride^b	Strattera	Lilly	Agent for attention deficit hyperactivity disorder	Oral	1-S	180
Bortezomib	Velcade	Millennium	Antineoplastic agent	Intravenous	1-P, H	197
Daptomycin	Cubicin	Cubist	Antibiotic	Intravenous	1-P	169
Efalizumab	Raptiva	Genentech; Xoma	Agent for psoriasis	Subcutaneous	S^c	186
Eletriptan hydrobromide^b	Relpax	Pfizer	Agent for migraine	Oral	1-S	182
Emtricitabine	Emtriva	Gilead Sciences	Antiviral agent	Oral	1-S	172
Enfuvirtide	Fuzeon	Roche; Trimeris	Antiviral agent	Subcutaneous	1-P, H	172
Eplerenone^c	Inspra	Pfizer	Agent for congestive heart failure and hypertension	Oral	1-S	177
Gefitinib	Iressa	AstraZeneca	Antineoplastic agent	Oral	1-P, H	196
Icodextrin^b	Extraneal	Baxter	Agent for peritoneal dialysis	Peritoneal	1-S	204
Laronidase	Aldurazyme	Genzyme	Agent for mucopolysaccharidosis	Intravenous	P, V^c	201
Memantine hydrochloride	Namenda	Forest	Agent for Alzheimer's disease	Oral	1-S, V	182
Mequinol/tretinoin^b	Solagé	Galderma	Depigmenting agent	Topical	1, 4-S	200
Miglustat	Zavesca	Actelion	Agent for Gaucher disease	Oral	1-S, V	203
Nitazoxanide^b	Alinia	Romark	Antiparasitic agent	Oral	1-P, V	176
Omalizumab	Xolair	Genentech; Novartis	Antiasthmatic agent	Subcutaneous	S^c	188
Palonosetron hydrochloride	Aloxi	MGI Pharma	Antiemetic agent	Intravenous	1-S	190
Pegvisomant	Somavert	Pfizer	Agent for acromegaly	Subcutaneous	1-P, V	195
Rosuvastatin calcium	Crestor	AstraZeneca	Antihyperlipidemic agent	Oral	1-S	178
Tadalafil	Cialis	Lilly; ICOS	Agent for erectile dysfunction	Oral	1-S	192
Tositumomab and iodine I-131 tositumomab	Bexxar	Corixa; GlaxoSmithKline	Antihyperlipidemic agent	Intravenous	P^c	198
Vardenafil hydrochloride	Levitra	Bayer; GlaxoSmithKline	Agent for erectile dysfunction	Oral	1-S	192

Table 2. Therapeutic Agents Approved by FDA but Not Marketed in 2003^a

Generic Name Trade Name Manufacturer Therapeutic Classification FDA Classification^b
Abarelix Plenaxis Praecis Antineoplastic agent 1-P
Epinastine hydrochloride Elestat Allergan Ophthalmic antihistamine 1-S
Gemifloxacin mesylate Factive Genesoft Antibacterial agent 1-S
Ibandronate sodium Boniva Roche Agent for osteoporosis 1-S
Prussian blue Radiogardase Heyl Agent for radiation contamination 1-P
Sertaconazole nitrate Ertaczo Mylan Topical antifungal agent 1-S

a These therapeutic agents were approved by FDA during 2003 but did not appear on the market before the end of the year. Therefore, they are not included in this review.
b FDA classification of new drugs: 1 = new molecular entity; P = priority review; S = standard review.

Generic Name	Trade Name	Manufacturer	Therapeutic Classification	FDA Classification^b
Abarelix	Plenaxis	Praecis	Antineoplastic agent	1-P
Epinastine hydrochloride	Elestat	Allergan	Ophthalmic antihistamine	1-S
Gemifloxacin mesylate	Factive	Genesoft	Antibacterial agent	1-S
Ibandronate sodium	Boniva	Roche	Agent for osteoporosis	1-S
Prussian blue	Radiogardase	Heyl	Agent for radiation contamination	1-P
Sertaconazole nitrate	Ertaczo	Mylan	Topical antifungal agent	1-S

Table 3. Antiviral Agents Indicated for Treatment of HIV Infection and AIDS

Nucleoside HIV reverse transcriptase inhibitors
Abacavir (Ziagen)
Didanosine (Videx, Videx EC)
Emtricitabine (Emtriva)
Lamivudine (Epivir)
Stavudine (Zerit)
Zalcitabine (Hivid)
Zidovudine (Retrovir)
Lamivudine/Zidovudine (Combivir)
Abacavir/Lamivudine/Zidovudine (Trizivir)
Nucleotide HIV reverse transcriptase inhibitor
Tenofovir (Viread)
Nonnucleoside HIV reverse transcriptase inhibitors
Delavirdine (Rescriptor)
Efavirenz (Sustiva)
Nevirapine (Viramune)
HIV protease inhibitors
Amprenavir (Agenerase)
Atazanavir (Reyataz)
Fosamprenavir (Lexiva)
Indinavir (Crixivan)
Lopinavir/ritonavir (Kaletra)
Nelfinavir (Viracept)
Ritonavir (Norvir)
Saquinavir (Fortovase, Invirase)
Fusion inhibitor
Enfuvirtide (Fuzeon)

Table 4. Selected New Indications and Dosage Forms

Generic Name Trade Name -- Manufacturer New Indication and/or New Dosage Form
Anakinra Kineret -- Amgen Slow progression of structural damage in patients with moderately to severely active rheumatoid arthritis
Aripiprazole Abilify -- Bristol-Myers Squibb To maintain stability in patients with schizophrenia
Azelaic acid Finacea -- Berlex Topical gel
Mild to moderate rosacea
Bupropion hydrochloride Wellbutrin XL -- GlaxoSmithKline Extended-release tablet for once-daily administration
Carvedilol Coreg -- GlaxoSmithKline Reduction of cardiovascular mortality in clinically stable patients who have survived acute phase of myocardial infarction and have left ventricular ejection fraction of 40% or less
Ciclopirox Loprox -- Medicis Shampoo
Seborrheic dermatitis of the scalp
Clonazepam Klonopin -- Roche Wafers (orally disintegrating tablets)
Desirudin Iprivask -- Aventis Injection for subcutaneous administration
Prophylaxis of deep-vein thrombosis in patients undergoing elective hip-replacement surgery
Estradiol Estrasorb -- Novavax Topical emulsion
Estradiol Femring -- Galen Vaginal ring
Etanercept Enbrel -- Amgen Ankylosing spondylitis; improvement of physical function in patients with moderately to severely active rheumatoid arthritis; inhibition of progression of structural damage in patients with active psoriatic arthritis
Famotidine Pepcid AC -- Johnson & Johnson-Merck Rx-to-OTC switch of 20-mg potency tablet
Fluticasone propionate/salmeterol Advair Diskus -- GlaxoSmithKline Chronic obstructive pulmonary disease associated with bronchitis
Fondaparinux sodium Arixtra -- Organon; Sanofi-Synthélabo Extended prophylaxis of deep-vein thrombosis in patients undergoing hip-fracture surgery
Fosamprenavir calcium (prodrug of amprenavir [Agenerase]) Lexiva -- GlaxoSmithKline Tablet
Combination treatment of HIV infection in adults
Gatifloxacin Zymar -- Allergan Ophthalmic solution
Bacterial conjunctivitis
Infliximab Remicade -- Centocor Reduction in number of draining rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease
Lamotrigine Lamictal -- GlaxoSmithKline Maintenance treatment of adults with bipolar I disorder to delay time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy
Latanoprost Xalatan -- Pfizer First-line treatment for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Leflunomide Arava -- Aventis Improvement of physical function in patients with rheumatoid arthritis
Levofloxacin Levaquin -- Ortho-McNeil Chronic bacterial prostatitis
Levonorgestrel/ethinyl estradiol Seasonale -- Duramed Extended-cycle (91-day) oral contraceptive
Linezolid Zyvox -- Pfizer Diabetic foot infections
Losartan Cozaar -- Merck Reduction in risk of stroke in patients with hypertension and left ventricular hypertrophy
Metformin hydrochloride Riomet -- Ranbaxy Oral solution
Montelukast sodium Singulair -- Merck Relief of symptoms of seasonal allergic rhinitis
Moxifloxacin Vigamox -- Alcon Ophthalmic solution
Bacterial conjunctivitis
Moxifloxacin Avelox -- Bayer Community-acquired pneumonia caused by penicillin-resistant strains of Streptococcus pneumoniae
Olanzapine Zyprexa -- Lilly Treatment of acute manic episodes associated with bipolar I disorder in combination with lithium or valproate
Oxybutynin Oxytrol -- Watson Transdermal system
Paroxetine hydrochloride controlled-release tablets Paxil CR -- GlaxoSmithKline Premenstrual dysphoric disorder; social anxiety disorder
Porfimer sodium Photofrin -- Axcan Ablating high-grade dysplasia in patients with Barrett's esophagus
Pyridostigmine bromide -- Increasing survival after exposure to Soman "nerve gas" poisoning
Ribavirin Rebetol -- Schering Oral solution
Risperidone Risperdal -- Janssen Acute manic or mixed episodes of bipolar I disorder
Risperidone Risperdal M -- TAB-Janssen Rapidly dissolving tablet
Risperidone Risperdal Consta -- Janssen Injection for intramuscular administration every 2 weeks
Sirolimus Rapamune -- Wyeth Maintenance therapy for kidney transplant rejection while cyclosporine is withdrawn from treatment regimen
Sirolimus Cypher -- Cordis Drug-eluting stent
Prevention of restenosis of de novo coronary lesions in patients with coronary artery disease
Somatropin Humatrope -- Lilly Idiopathic short stature
Testosterone Striant -- Columbia Buccal system
Valacyclovir Valtrex -- GlaxoSmithKline Suppression of recurrent genital herpes in HIV-infected patients; reduction in risk of heterosexual transmission of genital herpes to susceptible partners with healthy immune systems when used as suppressive therapy in combination with safer sex practices
Valganciclovir Valcyte -- Roche Prevention of cytomegalovirus disease in kidney, heart, and kidney-pancreas transplant patients at high risk
Voriconazole Vfend -- Pfizer Esophageal candidiasis
Zolmitriptan Zomig -- AstraZeneca Nasal spray

a	FDA classification of new drugs: 1 = new molecular entity; 4 = combination product; P = priority review; S = standard review; H = accelerated approval; V = designated orphan drug.
b	Approved by FDA before 2003 but not marketed until 2003.
c	A biological approved through an FDA procedure that does not assign a numerical classification.

a	These therapeutic agents were approved by FDA during 2003 but did not appear on the market before the end of the year. Therefore, they are not included in this review.
b	FDA classification of new drugs: 1 = new molecular entity; P = priority review; S = standard review.

Generic Name	Trade Name -- Manufacturer	New Indication and/or New Dosage Form
Anakinra	Kineret -- Amgen	Slow progression of structural damage in patients with moderately to severely active rheumatoid arthritis
Aripiprazole	Abilify -- Bristol-Myers Squibb	To maintain stability in patients with schizophrenia
Azelaic acid	Finacea -- Berlex	Topical gel
Azelaic acid	Finacea -- Berlex	Mild to moderate rosacea
Bupropion hydrochloride	Wellbutrin XL -- GlaxoSmithKline	Extended-release tablet for once-daily administration
Carvedilol	Coreg -- GlaxoSmithKline	Reduction of cardiovascular mortality in clinically stable patients who have survived acute phase of myocardial infarction and have left ventricular ejection fraction of 40% or less
Ciclopirox	Loprox -- Medicis	Shampoo
Ciclopirox	Loprox -- Medicis	Seborrheic dermatitis of the scalp
Clonazepam	Klonopin -- Roche	Wafers (orally disintegrating tablets)
Desirudin	Iprivask -- Aventis	Injection for subcutaneous administration
Desirudin	Iprivask -- Aventis	Prophylaxis of deep-vein thrombosis in patients undergoing elective hip-replacement surgery
Estradiol	Estrasorb -- Novavax	Topical emulsion
Estradiol	Femring -- Galen	Vaginal ring
Etanercept	Enbrel -- Amgen	Ankylosing spondylitis; improvement of physical function in patients with moderately to severely active rheumatoid arthritis; inhibition of progression of structural damage in patients with active psoriatic arthritis
Famotidine	Pepcid AC -- Johnson & Johnson-Merck	Rx-to-OTC switch of 20-mg potency tablet
Fluticasone propionate/salmeterol	Advair Diskus -- GlaxoSmithKline	Chronic obstructive pulmonary disease associated with bronchitis
Fondaparinux sodium	Arixtra -- Organon; Sanofi-Synthélabo	Extended prophylaxis of deep-vein thrombosis in patients undergoing hip-fracture surgery
Fosamprenavir calcium (prodrug of amprenavir [Agenerase])	Lexiva -- GlaxoSmithKline	Tablet
Fosamprenavir calcium (prodrug of amprenavir [Agenerase])	Lexiva -- GlaxoSmithKline	Combination treatment of HIV infection in adults
Gatifloxacin	Zymar -- Allergan	Ophthalmic solution
Gatifloxacin	Zymar -- Allergan	Bacterial conjunctivitis
Infliximab	Remicade -- Centocor	Reduction in number of draining rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease
Lamotrigine	Lamictal -- GlaxoSmithKline	Maintenance treatment of adults with bipolar I disorder to delay time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy
Latanoprost	Xalatan -- Pfizer	First-line treatment for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Leflunomide	Arava -- Aventis	Improvement of physical function in patients with rheumatoid arthritis
Levofloxacin	Levaquin -- Ortho-McNeil	Chronic bacterial prostatitis
Levonorgestrel/ethinyl estradiol	Seasonale -- Duramed	Extended-cycle (91-day) oral contraceptive
Linezolid	Zyvox -- Pfizer	Diabetic foot infections
Losartan	Cozaar -- Merck	Reduction in risk of stroke in patients with hypertension and left ventricular hypertrophy
Metformin hydrochloride	Riomet -- Ranbaxy	Oral solution
Montelukast sodium	Singulair -- Merck	Relief of symptoms of seasonal allergic rhinitis
Moxifloxacin	Vigamox -- Alcon	Ophthalmic solution
Moxifloxacin	Vigamox -- Alcon	Bacterial conjunctivitis
Moxifloxacin	Avelox -- Bayer	Community-acquired pneumonia caused by penicillin-resistant strains of Streptococcus pneumoniae
Olanzapine	Zyprexa -- Lilly	Treatment of acute manic episodes associated with bipolar I disorder in combination with lithium or valproate
Oxybutynin	Oxytrol -- Watson	Transdermal system
Paroxetine hydrochloride controlled-release tablets	Paxil CR -- GlaxoSmithKline	Premenstrual dysphoric disorder; social anxiety disorder
Porfimer sodium	Photofrin -- Axcan	Ablating high-grade dysplasia in patients with Barrett's esophagus
Pyridostigmine bromide	--	Increasing survival after exposure to Soman "nerve gas" poisoning
Ribavirin	Rebetol -- Schering	Oral solution
Risperidone	Risperdal -- Janssen	Acute manic or mixed episodes of bipolar I disorder
Risperidone	Risperdal M -- TAB-Janssen	Rapidly dissolving tablet
Risperidone	Risperdal Consta -- Janssen	Injection for intramuscular administration every 2 weeks
Sirolimus	Rapamune -- Wyeth	Maintenance therapy for kidney transplant rejection while cyclosporine is withdrawn from treatment regimen
Sirolimus	Cypher -- Cordis	Drug-eluting stent
Sirolimus	Cypher -- Cordis	Prevention of restenosis of de novo coronary lesions in patients with coronary artery disease
Somatropin	Humatrope -- Lilly	Idiopathic short stature
Testosterone	Striant -- Columbia	Buccal system
Valacyclovir	Valtrex -- GlaxoSmithKline	Suppression of recurrent genital herpes in HIV-infected patients; reduction in risk of heterosexual transmission of genital herpes to susceptible partners with healthy immune systems when used as suppressive therapy in combination with safer sex practices
Valganciclovir	Valcyte -- Roche	Prevention of cytomegalovirus disease in kidney, heart, and kidney-pancreas transplant patients at high risk
Voriconazole	Vfend -- Pfizer	Esophageal candidiasis
Zolmitriptan	Zomig -- AstraZeneca	Nasal spray

Table 1. New Therapeutic Agents Marketed in the United States in 2003

Table 2. Therapeutic Agents Approved by FDA but Not Marketed in 2003a

Table 3. Antiviral Agents Indicated for Treatment of HIV Infection and AIDS

Table 4. Selected New Indications and Dosage Forms

Table 2. Therapeutic Agents Approved by FDA but Not Marketed in 2003^a