New Drugs Approved by Us FDA in 2003 To 2008

NEW DRUGS APPROVED BY US FDA IN
2008
Cleviprex (clevidipine); The Medicines Company; For the treatment of hypertension when oral
therapy is not feasible or not desirable, Approved August 2008
Trilipix (fenofibric acid); Abbott Laboratories; For the treatment of dyslipidemia,
hypertriglyceridemia and hyperlipidemia, Approved December 2008
Accretropin (somatropin rDNA Original); Cangene; For the treatment of growth failure in
pediatrics, Approved January 2008
Welchol (colesevelam hydrochloride); Daiichi Sankyo; For the improvement of glycemic control in
adults with type 2 diabetes mellitus, Approved January 2008
Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy
in adults and adolescents, Approved January 2008
Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008
Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-
Gastaut syndrome in pediatrics and adults, Approved November 2008
Cimzia (certolizumab pegol); UCB; For the treatment of Crohn’s disease, Approved April 2008
Cleviprex (clevidipine); The Medicines Company; For the treatment of hypertension when oral
therapy is not feasible or not desirable, Approved August 2008
Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer,
Approved December of 2008
Intelence (etravirine); Tibotec; For the treatment of HIV-1, Approved January 2008
Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic
disorder, seizures and migraine headaches, Approved July 2008
Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe
Crohn’s disease, Approved January 2008
Vimpat (lacosamide); Schwarz Pharma; For the treatment of partial-onset seizures in adults with
epilepsy, Approved October 2008
Welchol (colesevelam hydrochloride); Daiichi Sankyo; For the improvement of glycemic control in
adults with type 2 diabetes mellitus, Approved January 2008
Cimzia (certolizumab pegol); UCB; For the treatment of Crohn’s disease, Approved April 2008
Entereg (alvimopan); GlaxoSmithKline; For the treatment of postoperative ileus, Approved May
2008
Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus
gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008
Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and
vomiting, Approved September 2008
Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and
multiple myeloma, Approved December 2008
Nplate (romiplostim); Amgen; For the treatment of thrombocytopenia in patients with chronic
immune (idiopathic) thrombocytopenic purpura, Approved August 2008
Promacta (eltrombopag); GlaxoSmithKline; For the treatment of thrombocytopenia, Approved
November 2008
Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved
Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals Inc; For the treatment of
seasonal and perennial allergic rhinitis, Approved October 2008
Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in
adolescents/adults with Hereditary Angioedema, Approved October 2008
Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or
pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008
Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August
2008
Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis,
Approved April 2008
Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August
2008
Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis,
Approved April 2008
Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's
disease, Approved August 2008
Toviaz (fesoterodine fumarate); Pfizer; For the treatment of overactive bladder, Approved October
2008
Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain
associated with ocular surgery, Approved June 2008
Lusedra (fospropofol disodium); Elan Pharmaceuticals; A sedative-hypnotic agent indicated for
monitored anesthesia care sedation, Approved December of 2008
Nucynta (tapentadol); Ortho-McNeil Pharmaceutical; moderate to severe acute pain, Approved
November 2008
Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's
disease, Approved August 2008
Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate
therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008
Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and
multiple myeloma, Approved December 2008
Treanda (bendamustine hydrochloride); Cephalon; For the treatment of Chronic lymphocytic
leukemia and B-cell non-Hodgkin’s lymphoma, Approved October 2008
Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures,
Approved October 2008
Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain
associated with ocular surgery, Approved June 2008
Approved April 2008
Accretropin (somatropin rDNA Original); Cangene; For the treatment of growth failure in
pediatrics, Approved January 2008
Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in
adolescents/adults with Hereditary Angioedema, Approved October 2008
Approved April 2008
Approved April 2008
Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures,
Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate
therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008
Aplenzin (bupropion hydrobromide); Biovail Laboratories; For the treatment of major depressive
disorder, Approved April 2008
Approved April 2008
Approved April 2008
2007
Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo; For the treatment of
hypertension, Approved September 2007
Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and
hypertriglyceridemia, Approved August 2007
Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved
June 2007
Soliris (eculizumab); Alexion; For the treatment of PNH, aHUS and generalized Myasthenia Gravis
, Approved March 2007
Tekturna (aliskiren); Novartis; For the treatment of hypertension, Approved March 2007
Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus
aureus or Streptococcus pyogenes, Approved April 2007
Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007
Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic
rhinitis and urticaria, Approved May 2007
Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due to
menopause, Approved July 2007
Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and
hypertriglyceridemia, Approved August 2007
Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly,
Approved August 2007
Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central precocious
puberty, Approved May 2007
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of
muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007
Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo; For the treatment of
hypertension, Approved September 2007
Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and
urinary tract infections, Approved October 2007
Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and
reduction of breast cancer risk in postmenopausal women, Approved September 2007
Exelon (rivastigmine tartrate); Novartis; For the treatment of Alzheimer's and Parkinson's disease-
related dementia, Approved July 2007
Hycamtin (topotecan hydrochloride); GlaxoSmithKline; For the treatment of small cell lung cancer,
Isentress (raltegravir); Merck; For the treatment of HIV-1, Approved October 2007
Ixempra (ixabepilone); Bristol-Myers Squibb; For the treatment of breast cancer, Approved October
2007
June 2007
Neupro (rotigotine); Schwarz Pharma; For the treatment of Parkinson's disease, Approved May
2007
Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis, Approved
August 2007
Renvela (sevelamer carbonate); Genzyme; For the control of serum phosphorus in patients with
chronic kidney disease on dialysis, Approved October 2007
Selzentry (maraviroc); Pfizer; For the treatment of CCR5-tropic HIV-1, Approved August 2007
Tekturna (aliskiren); Novartis; For the treatment of hypertension, Approved March 2007
Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007
Tykerb (lapatinib); GlaxoSmithKline; For the treatment of breast cancer, Approved March 2007
Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-
Deficit/Hyperactivity Disorder, Approved February 2007
Kuvan (sapropterin dihydrochloride); BioMarin Pharmaceuticals; For the treatment of
hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria, Approved
December 2007
Mircera (methoxy polyethylene glycol-epoetin beta); Roche; For the treatment of anemia
associated with chronic renal failure, Approved November 2007
AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved April
2007
Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007
Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial
allergic rhinitis, Approved April 2007
August 2007
Reclast (zoledronic acid); Novartis; For the treatment of Paget's disease, Approved April 2007
Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly,
Approved August 2007
Mircera (methoxy polyethylene glycol-epoetin beta); Roche; For the treatment of anemia
associated with chronic renal failure, Approved November 2007
Renvela (sevelamer carbonate); Genzyme; For the control of serum phosphorus in patients with
chronic kidney disease on dialysis, Approved October 2007
Exelon (rivastigmine tartrate); Novartis; For the treatment of Alzheimer's and Parkinson's disease-
related dementia, Approved July 2007
Neupro (rotigotine); Schwarz Pharma; For the treatment of Parkinson's disease, Approved May
2007
Nuvigil (armodafinil); Cephalon; For the treatment of excessive sleepiness, Approved June 2007
Zingo (lidocaine hydrochloride monohydrate); Powder Pharmaceuticals; For local analgesia prior
to venipuncture or peripheral intravenous cannulation, Approved August 2007
August 2007
Hycamtin (topotecan hydrochloride); GlaxoSmithKline; For the treatment of small cell lung cancer,
Ixempra (ixabepilone); Bristol-Myers Squibb; For the treatment of breast cancer, Approved October
2007
Tasigna (nilotinib hydrochloride monohydrate); Novartis; For the treatment of chronic
myelogenous leukemia, Approved October 2007
Tykerb (lapatinib); GlaxoSmithKline; For the treatment of breast cancer, Approved March 2007
AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved April
Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central precocious
puberty, Approved May 2007
Zingo (lidocaine hydrochloride monohydrate); Powder Pharmaceuticals; For local analgesia prior
to venipuncture or peripheral intravenous cannulation, Approved August 2007
June 2007
2006
Ranexa (ranolazine); CV Therapeutics; For the treatment of chronic angina in patients failing first-
line therapy, Approved January 2006
Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006
Verdeso (desonide); Connetics Corporation; For the treatment of atopic dermatitis, Approved
September 2006
Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with
menopause, Approved December 2006
Januvia (sitagliptin phosphate); Merck; For the treatment of type II diabetes, Approved October
2006
Eraxis (anidulafungin); Pfizer; For the treatment of Candida fungal infections, Approved February
2006
Januvia (sitagliptin phosphate); Merck; For the treatment of type II diabetes, Approved October
2006
Noxafil (posaconazole); Schering-Plough; For the treatment of fungal infections, Approved in
September 2006
Prezista (darunavir); Tibotec; For the treatment of treatment-resistant HIV infections, Approved
June 2006
Ranexa (ranolazine); CV Therapeutics; For the treatment of chronic angina in patients failing first-
line therapy, Approved January 2006
Vectibix (panitumumab); Amgen; For the treatment of colorectal cancer, Approved September
2006
Verdeso (desonide); Connetics Corporation; For the treatment of atopic dermatitis, Approved
September 2006
Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of
alcohol dependence, Approved April 2006
Amitiza (lubiprostone); Sucampo/Takeda; For the treatment of chronic idiopathic constipation,
Approved January 2006
Dacogen (decitabine); MGI Pharma; For the treatment of both treatment-naïve and -experienced
Myelodysplastic Syndromes, Approved May 2006
Tyzeka (telbivudine); Idenix Pharma; For the treatment of hepatitis B virus, Approved October 2006
2006
Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine);
Merck; For the prevention of cervical cancer associated with human papillomavirus, Approved June
2006
September 2006
June 2006
Rotateq (rotavirus vaccine, live oral pentavalent); Merck; For the prevention of gastroenteritis
associated with rotavirus infections in infants, Approved February 2006
Veregen (kunecatechins); Medigene; For the treatment of external genital and perianal warts,
2006
September 2006
June 2006
Invega (paliperidone); Janssen Pharmaceuticals; For the treatment of schizophrenia, Approved
December 2006
Avastin (bevacizumab); Genentech; For the treatment of non–squamous non–small cell lung
cancer, Approved October 2006
Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine);
Merck; For the prevention of cervical cancer associated with human papillomavirus, Approved June
2006
Sprycel (dasatinib); Bristol-Myers Squibb; For the treatment of imatinib-resistant chronic myeloid
leukemia, Approved June 2006
Sutent (sunitinib); Pfizer; For the treatment of kidney cancer and gastrointestinal stromal tumors,
Approved January 2006
Vectibix (panitumumab); Amgen; For the treatment of colorectal cancer, Approved September
2006
Lucentis (ranibizumab); Genentech; For the treatment of neovascular (wet) age related macular
degeneration, Approved June 2006
Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II
(Hunter Syndrome), Approved July 2006
Myozyme (alglucosidase alfa); Genzyme; For the treatment of Pompe disease (glycogen storage
disease type II), Approved April 2006
Chantix (varenicline); Pfizer; For the treatment of nicotine addiction, Approved May 2006
Invega (paliperidone); Janssen Pharmaceuticals; For the treatment of schizophrenia, Approved
December 2006
Avastin (bevacizumab); Genentech; For the treatment of non–squamous non–small cell lung
cancer, Approved October 2006
Brovana (arformoterol tartrate); Sepracor; For the treatment of Chronic Obstructive Pulmonary
Disease, Approved in October 2006
Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II
(Hunter Syndrome), Approved July 2006
2005
BiDil (isosorbide dinitrate/hydralazine hydrochloride); NitroMed; For the treatment of heart
failure in black patients, Approved June, 2005
Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure and intra-
abdominal infections and bacterial pneumonia, Approved 2005
ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride); Takeda; For the
treatment of type 2 diabetes, Approved August of 2005
Byetta (exenatide); Amylin/Eli Lilly; For the adjunctive treatment of Type 2 diabetes mellitus,
Approved April, 2005
Increlex (mecasermin); Tercica; For the treatment of growth failure due to Primary IGFD, Approved
August 2005
Symlin (pramlintide); Amylin Pharmaceuticals; For the treatment of type I and type II diabetes,
Approved March 2005
ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride); Takeda; For the
treatment of type 2 diabetes, Approved August of 2005
Aptivus (tipranavir); Boehringer Ingelheim; For the adjunctive treatment of HIV-1 infections,
Approved June, 2005
BiDil (isosorbide dinitrate/hydralazine hydrochloride); NitroMed; For the treatment of heart
failure in black patients, Approved June, 2005
Boniva (ibandronate); Roche / GlaxoSmithKline; For the treatment and prevention of osteoporosis,
Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005
Byetta (exenatide); Amylin/Eli Lilly; For the adjunctive treatment of Type 2 diabetes mellitus,
Approved April, 2005
Nexavar (sorafenib); Bayer/Onyx; For the Treatment of Renal Cell Carcinoma, Approved December
2005
Orencia (abatacept); Bristol-Myers Squibb; For the Treatment of Rheumatoid Arthritis, Approved
December 2005
Symlin (pramlintide); Amylin Pharmaceuticals; For the treatment of type I and type II diabetes,
Approved March 2005
Tysabri (natalizumab); Elan Pharmaceuticals / Biogen Idec; For the treatment of relapsing forms of
multiple sclerosis, Approved November 2004 -- Updated: Suspended February 2005--Updated:
sBLA
Revlimid (lenalidomide); Celgene; For the treatment of low- and intermediate-1-risk
myelodysplastic syndromes, Approved December 2005
Baraclude (entecavir); Bristol-Myers Squibb; For the treatment of chronic hepatitis B infections with
evidence of active viral replication, Approved March, 2005
2005
Approved June, 2005
Approved June, 2005
Boniva (ibandronate); Roche / GlaxoSmithKline; For the treatment and prevention of osteoporosis,
Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005
Naglazyme (galsulfase); BioMarin Pharmaceuticals; For the treatment of mucopolysaccharidosis VI
(Maroteaux-Lamy syndrome), Approved May 2005
Vaprisol (conivaptan); Astellas Pharma US, Inc; For the treatment of euvolemic hyponatremia,
Approved December 2005
Rozerem (ramelteon); Takeda; For the treatment of sleep-onset insomnia, Approved July, 2005
Tysabri (natalizumab); Elan Pharmaceuticals / Biogen Idec; For the treatment of relapsing forms of
multiple sclerosis, Approved November 2004 -- Updated: Suspended February 2005--Updated:
sBLA
Arranon (nelarabine); GlaxoSmithKline; For the treatment of T-cell acute lymphoblastic leukemia
and T-cell lymphoblastic lymphoma, Approved October 2005
2005
Orencia (abatacept); Bristol-Myers Squibb; For the Treatment of Rheumatoid Arthritis, Approved
December 2005
2004
Caduet (amlodipine/atorvastatin); Pfizer; For the treatment of hypertension, chronic stable angina
and vasospastic angina, Approved January 2004
Apokyn (apomorphine hydrochloride); Mylan Laboratories; For the treatment of acute, intermittent
hypomobility episodes associated with advanced Parkinson’s disease, Approved April, 2004
Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or
rectum, Approved February 2004
Caduet (amlodipine/atorvastatin); Pfizer; For the treatment of hypertension, chronic stable angina
and vasospastic angina, Approved January 2004
Campral (acamprosate calcium); Forest Laboratories; For the treatment of alcohol dependence
and the maintenance of alcohol abstinence, Approved August, 2004
Cymbalta (duloxetine); Eli Lilly; For the treatment of major depressive disorder, Approved August
2004
Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing,
metastatic colorectal cancer, Approved February 2004
EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals; For the treatment of vasomotor symptoms
and vulvar and vaginal atrophy associated with menopause, Approved April 2004
Lyrica (pregabalin); Pfizer; For the treatment of pain associated with diabetic peripheral neuropathy
and postherpetic neuralgia, Approved December 2004
Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim; For the treatment of
bronchospasm associated with chronic obstructive pulmonary disease, Approved February 2004
Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals; For the treatment of advanced
refractory metastatic non-small cell lung cancer, Approved November, 2004
Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 --
UPDATED: WITHDRAWN OCTOBER 2004
Vidaza (azacitidine); Pharmion Corporation; For the treatment of several myelodysplastic syndrome
subtypes including refractory and chronic myelomonocytic leukemias, Approved May 2004
Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of Travelers' diarrhea caused by
noninvasive strains of Escherichia coli, Approved May 2004
Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis, bacterial
sinusitis and Community-acquired pneumonia., Approved April 2004
Tindamax, tinidazole; Presutti Laboratories; For the treatment of microbial infections, including
trichomoniasis, giardiasis, and amebiasis, Approved May, 2004
Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of Travelers' diarrhea caused by
noninvasive strains of Escherichia coli, Approved May 2004
Fosrenol, lanthanum carbonate; Shire Pharmaceuticals; For the treatment of hyperphosphatemia
related to kidney dysfunction, Approved October, 2004
Sanctura (trospium chloride); Indevus Pharmaceuticals; For the treatment of overactive bladder
with symptoms of urge urinary incontinence, Approved May, 2004
Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and
hypercalcemia in parathyroid carcinoma patients, Approved March 2004
Vesicare (solifenacin succinate); Yamanouchi, GlaxoSmithKline; For the treatment of overactive
bladder with symptoms of urge urinary incontinence, Approved November, 2004
Apokyn (apomorphine hydrochloride); Mylan Laboratories; For the treatment of acute, intermittent
hypomobility episodes associated with advanced Parkinson’s disease, Approved April, 2004
Lunesta (eszopiclone); Sepracor; For the treatment of insomnia and sleep maintenance, Approved
December 2004
Lyrica (pregabalin); Pfizer; For the treatment of pain associated with diabetic peripheral neuropathy
and postherpetic neuralgia, Approved December 2004
EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals; For the treatment of vasomotor symptoms
and vulvar and vaginal atrophy associated with menopause, Approved April 2004
Alimta (pemetrexed for injection); Eli Lilly; For the treatment of malignant pleural mesothelioma,
Approved February 2004
Clolar (clofarabine); Genzyme; For the treatment of acute lymphoblastic leukemia in pediatric
patients, Approved December, 2004
Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and
hypercalcemia in parathyroid carcinoma patients, Approved March 2004
Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals; For the treatment of advanced
refractory metastatic non-small cell lung cancer, Approved November, 2004
Macugen (pegaptanib); Pfizer / Eyetech Pharmaceuticals; For the treatment of wet age-related
macular degeneration., Approved December 2004
Campral (acamprosate calcium); Forest Laboratories; For the treatment of alcohol dependence
Cymbalta (duloxetine); Eli Lilly; For the treatment of major depressive disorder, Approved August
2004
Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis, bacterial
sinusitis and Community-acquired pneumonia., Approved April 2004
Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim; For the treatment of
bronchospasm associated with chronic obstructive pulmonary disease, Approved February 2004
2003
Crestor (rosuvastatin calcium); AstraZeneca; For the treatment of primary hypercholesterolemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia, Approved August 2003
Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to
sexual activity in men, Approved September 2003
Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved
January 2003
Finacea (azelaic acid) Gel, 15%; Berlex Laboratories; Gel formulation for the treatment of rosacea.,
January 2003
Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in
subjects aged 5 to 65, Approved May 2003
Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients,
Approved April 2003
Somavert (pegvisomant); Pharmacia & Upjohn; Injectable formulation for the treatment of
acromegaly, Approved March 2003
January 2003
Cialis (tadalafil); Eli Lilly; Oral agent for the treatment for erectile dysfunction, Approved December
2003
Finacea (azelaic acid) Gel, 15%; Berlex Laboratories; Gel formulation for the treatment of rosacea.,
January 2003
Fuzeon (enfuvirtide); Trimeris, Roche; For the treatment of HIV-1 infection in combination with
other antiretroviral agents, Approved March 2003
Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer,
Approved May 2003
Lexiva (fosamprenavir calcium); GlaxoSmithKline; For the treatment of HIV infection in adults in
combination with other antiretroviral agents., Approved October 2003
Namenda (memantine HCl); Forest Laboratories; For the treatment of moderate to severe
dementia of the Alzheimer’s type., Approved October 2003
Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals; For treatment of
advanced prostate cancer, Approved December 2003
Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and
treatment of vasomotor menopause symptoms, Approved July of 2003
Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in
combination with other antiretroviral agents, Approved July 2003
UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the
signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Xolair (omalizumab); Genentech; For the treatment of asthma, Approved June 2003
Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting
associated with emetogenic cancer chemotherapy, Approved August 2003
Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with
chemotherapy, Approved March 2003
Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of
overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved
March 2003
Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma
following chemotherapy relapse, Approved June 2003
Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase
inhibitor deficiency (Alpha-1) and emphysema, Approved July 2003
January 2003
FluMist ( Influenza Virus Vaccine); MedImmune; For the prevention of disease caused by
influenza A and B viruses, Approved June 2003
influenza A and B viruses, Approved June 2003
Somavert (pegvisomant); Pharmacia & Upjohn; Injectable formulation for the treatment of
acromegaly, Approved March 2003
Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple
myeloma patients who have received at least two prior therapies., Approved May 2003
Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients,
Approved April 2003
Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of
overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved
March 2003
2003
Namenda (memantine HCl); Forest Laboratories; For the treatment of moderate to severe
dementia of the Alzheimer’s type., Approved October 2003
Seasonale, Lo Seasonale, Seasonique (ethinylestradiol + levonorgestrel); Duramed
Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting
associated with emetogenic cancer chemotherapy, Approved August 2003
Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma
following chemotherapy relapse, Approved June 2003
Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with
chemotherapy, Approved March 2003
Approved May 2003
Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple
myeloma patients who have received at least two prior therapies., Approved May 2003
Approved May 2003
Xolair (omalizumab); Genentech; For the treatment of asthma, Approved June 2003
Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase
inhibitor deficiency (Alpha-1) and emphysema, Approved July 2003
2003
influenza A and B viruses, Approved June
This list [PAGES 01 TO 22 ] has been compiled from the US FDA website by
Dr Prem R Goel
BSc [Bombay],BPharm[Nagpur],MPharm[Bombay]
MS,PhD[USA]MBA[USA]MIQA[UK]
goelngoelassociatesplc
drpremrgoel@gmail.com
+91 7600135939
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