Approved Drugs for Hematology

Drugs Approved in 2009

Atryn (antithrombin recombinant lyophilized powder for reconstitution); GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009

Efient (prasugrel); Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute coronary syndromes, Approved July 2009

Elitek (rasburicase); sanofi-aventis; For the management of plasma uric acid levels in adults with malignancies, Approved October 2009

Feraheme (ferumoxytol); AMAG; For the treatment of iron deficiency anemia associated with chronic kidney disease, Approved June 2009

Folotyn (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell lymphoma, Approved September 2009

Samsca (tolvaptan); Otsuka; For the treatment of hyponatremia, Approved May of 2009

Drugs Approved in 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

Drugs Approved in 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

Soliris (eculizumab); Alexion Pharm; For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007

Drugs Approved in 2006

Dacogen (decitabine); MGI Pharma; For the treatment of both treatment-naïve and -experienced Myelodysplastic Syndromes, Approved May 2006

Drugs Approved in 2005

Revlimid (lenalidomide); Celgene; For the treatment of low- and intermediate-1-risk myelodysplastic syndromes, Approved December 2005

Drugs Approved in 2004

Vidaza (azacitidine); Pharmion Corporation; For the treatment of several myelodysplastic syndrome subtypes including refractory and chronic myelomonocytic leukemias, Approved May 2004

Drugs Approved in 2003

Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse, Approved June 2003

Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003

Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003

Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema, Approved July 2003

Drugs Approved in 2002

Neulasta; Amgen; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy, Approved January 2002

Drugs Approved in 2001

Arixtra; Organon, Sanofi-Synthelabo; Injectable solution for the prevention of deep vein thrombosis, Approved December 2001

Drugs Approved in 2000

Argatroban Injection; Texas Biotechnology Corporation, SmithKline Beecham; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia., Approved June 2000

Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the treatment of acute symptomatic deep vein thrombosis, Approved July 2000

Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia A, Approved June 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000

Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000

Drugs Approved in 1999

Aggrenox; Boehringer Ingelheim; Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999

Busulflex; Orphan Medical; For use in combination for the treatment of leukemia, Approved February 1999

Ferrlecit; R&D Laboratories; For the treatment of iron deficiency anemia., Approved February 1999

Fragmin; Pharmacia & Upjohn; Treatment of prophylaxis of deep vein thrombosis (DVT), Approved March 1999

Lovenox (enoxaparin sodium) Injection; Rhone Poulenc Rorer; Treatment for acute deep vein thrombosis, Approved January 1999

Drugs Approved in 1998

Actonel; Procter & Gamble, Hoechst Marion Roussel; Treatment for Paget's Disease, Approved April 1998

Droxia; Bristol-Myers Squibb; Treatment for sickle-cell anemia, Approved March 1998

Glucagon; Eli Lilly; Treatment for severe Hypoglycemia, Approved September 1998

Lovenox (enoxaparin sodium) Injection; Rhone Poulenc Rorer; Treatment for prevention of blood clots following hip-replacement surgery, Approved February 1998

Neupogen; Amgen; Treatment for slow white blood cell recovery following chemotherapy, Approval April 1998

Refludan; Hoechst Marion Roussel; Treatment of heparin-induced thrombocytopenia type II, Approved March 1998

Drugs Approved in 1997

Agrylin (anagrelide HCL); Roberts Pharmaceutical; Treatment for thrombocythemia, Approved March 1997

BeneFIX (coagulation Factor IX (recombinant)); Genetics Institute; Treatment for hemophilia B, Approved February 1997

Glyburide Tablets; Roche; Treatment for blood-glucose lowering, Approved December 1997

Glyburide Tablets; Mova Pharmaceutical; Generic version of Glynase PresTab, Approved December 1997

Lovenox (enoxaparin sodium) Injection; Rhone Poulenc Rorer; Treatment for deep vein thrombosis, Approved May 1997

Neumega; Genetics Institute; Treatment for thrombocytopenia, Approved November 1997

Rituxan; Biogen IDEC, Genentech; Treatment for non-hodgkin's lymphoma, Approved November 1997

Drugs Approved in 1996

AlphaNine SD Coagulation Factor IX (Human); Alpha Therapeutic Corporation; Treatment for the prevention and control of bleeding in subjects with hemophilia, Approved July 1996

BeneFIX (coagulation Factor IX (recombinant)); Genetics Institute; Treatment for hemophilia B, Recommended for approval December 1996

Gastrocrom Oral Concentrate (cromolyn sodium); Rhone Poulenc Rorer; Treatment for mastocytosis, Approved April 1996

Leukine (sargramostim); Immunex; Treatment for the replenishment of white blood cells, Approved November 1996

Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals; Treatment for vitamin B-12 deficiency, Approved November 1996

Pravachol (pravastatin sodium); Bristol-Myers Squibb; Treatment for cholesterol-lowering, Approved July 1996

Visipaque (iodixanol); Nycomed; Diagnostic contrast agent, Approved April 1996