Approved Drugs for Hematology

Drugs Approved in 2008

Drugs Approved in 2007

• Kuvan (sapropterin dihydrochloride); For the treatment of hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria; Biomarin; Approved December 2007
• Mircera (methoxy polyethylene glycol-epoetin beta); For the treatment of anemia associated with chronic renal failure; Hoffman La-Roche; Approved November 2007
• Soliris (eculizumab); For the treatment of paroxysmal nocturnal hemoglobinuria; Alexion Pharm; Approved March 2007

Drugs Approved in 2006

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

Drugs Approved in 2005

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

Drugs Approved in 2004

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

Drugs Approved in 2003

• Bexxar; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse; Corixa; Approved June 2003
• Levitra (vardenafil); For the treatment of erectile dysfunction related to sexual activity in men; Bayer, GlaxoSmithKline; Approved September 2003
• Reyataz (atazanavir sulfate); For the treatment of HIV-1 infection in combination with other antiretroviral agents; Bristol-Myers Squibb; Approved July 2003
• Zemaira (alpha1-proteinase inhibitor); For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema; Aventis Behring; Approved July 2003

Drugs Approved in 2002

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

Drugs Approved in 2001

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

Drugs Approved in 2000

• Argatroban Injection; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.; Texas Biotechnology Corporation, SmithKline Beecham; Approved June 2000
• Innohep (tinzaparin sodium) injectable; For the treatment of acute symptomatic deep vein thrombosis; Dupont Pharmaceuticals; Approved July 2000
• Venofer (iron sucrose injection); For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis; Luitpold Pharmaceuticals; Approved November 2000

Drugs Approved in 1999

• Aggrenox; Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke; Boehringer Ingelheim; Approved November 1999
• Busulflex; For use in combination for the treatment of leukemia; Orphan Medical; Approved February 1999
• Ferrlecit; For the treatment of iron deficiency anemia.; R&D Laboratories; Approved February 1999
• Fragmin; Treatment of prophylaxis of deep vein thrombosis (DVT); Pharmacia & Upjohn; Approved March 1999
• Lovenox (enoxaparin sodium) Injection; Treatment for acute deep vein thrombosis; Rhone Poulenc Rorer; Approved January 1999

Drugs Approved in 1998

• Actonel; Treatment for Paget's Disease; Procter & Gamble, Hoechst Marion Roussel; Approved April 1998
• Droxia; Treatment for sickle-cell anemia; Bristol-Myers Squibb; Approved March 1998
• Glucagon; Treatment for severe Hypoglycemia; Eli Lilly; Approved September 1998
• Lovenox; Treatment for prevention of blood clots following hip-replacement surgery; Rhone Poulenc Rorer; Approved February 1998
• Neupogen; Treatment for slow white blood cell recovery following chemotherapy; Amgen; Approval April 1998
• Refludan; Treatment of heparin-induced thrombocytopenia type II; Hoechst Marion Roussel; Approved March 1998

Drugs Approved in 1997

• AGRYLIN (anagrelide HCI); Treatment for thrombocythemia; Roberts Pharmaceutical; Approved March 1997
• BENEFIX (Coagulation Factor IX--Recombinant); Treatment for hemophilia B; Genetics Institute; Approved February 1997
• Glyburide Tablets; Generic version of Glynase PresTab; Mova Pharmaceutical; Approved December 1997
• Glyburide Tablets; Treatment for blood-glucose lowering; Roche; Approved December 1997
• Lovenox (enoxaparin sodium) Injection; Treatment for deep vein thrombosis; Rhone Poulenc Rorer; Approved May 1997
• Neumega; Treatment for thrombocytopenia; Genetics Institute; Approved November 1997
• Rituxan; Treatment for non-hodgkin's lymphoma; Idec Pharmaceuticals, Genentech; Approved November 1997

Drugs Approved in 1996

• AlphaNine SD Coagulation Factor IX (Human); Treatment for the prevention and control of bleeding in subjects with hemophilia; Alpha Therapeutic Corporation; Approved July 1996
• BeneFIX, Coagulation Factor IX (Recombinant); Treatment for hemophilia B; Genetics Institute; Recommended for approval December 1996
• Gastrocrom Oral Concentrate (cromolyn sodium); Treatment for mastocytosis; Rhone Poulenc Rorer; Approved April 1996
• Leukine (sargramostim); Treatment for the replenishment of white blood cells; Immunex; Approved November 1996
• Nascobal Gel (Cyanocobalamin, USP); Treatment for vitamin B-12 deficiency; Questcor Pharmaceuticals; Approved November 1996
• Pravachol (pravastatin sodium); Treatment for cholesterol-lowering; Bristol-Myers Squibb; Approved July 1996
• Visipaque (iodixanol); Diagnostic contrast agent; Nycomed; Approved April 1996

Drugs Approved in 1995