The Biopharmaceuticals

FDA-Approved Biopharmaceutical Drugs and Vaccines

The following biopharmaceutical agents have been approved by the Food and Drug Administration for marketing in the United States. The trademarked name is followed by the generic name of the drug in parentheses.
Acctimmune (gamma interferon)
Genentech, Inc.Approved for use in the management of chronic granulomatous disease (December, 1990).
Activase (recombinant alteplase)
Genentech, Inc.Approved for use in the treatment of myocardial infarction (November, 1987) and acute pulmonary embolism (June, 1990).
Adagen (adenosine deaminase)
Enzon, Inc.Approved for use in the treatment of infants and children with severe immunodeficiency (March, 1990).
Alferon N
Interferon Sciences, Inc.Approved for use in treating genital warts (October, 1989).
Betaseron (recombinant interferon beta 1-B)
Berlex Laboratories/Chiron Corp.Approved for use in the management of relapsing, remitting multiple sclerosis (August, 1993).
Ceredase (alglucerase)
Genzyme Corp.Approved for use in treating Type 1 Gaucher's disease (April, 1991).
Cerezyme (imiglucerase)
Genzyme Corp.Approved for use in treating Type 1 Gaucher's disease (June, 1994).
Engerix-B
SmithKline BeechamApproved for use as a hepatitis B vaccine (September, 1989).
EPOGEN (epoetin alfa)
Amgen Ltd.Approved for use in treating anemia associated with chronic renal failure and anemia in Retrovir-treated, HIV-infected patients (June, 1989).
Humatrope (somatropin)
Eli Lilly & Co.Approved for treating human growth hormone deficiency in children (March, 1987).
Humulin (recombinant human insulin)
Eli Lilly & Co.Approved for the treatment of diabetes (October, 1982).
Intron A (alpha-interferon)
Schering-Plough Corp.Approved for the treatment of hairy cell leukemia (June, 1986), genital warts (June, 1988), AIDS-related Kaposi's sarcoma (November, 1988), non-A, non-B hepatitis (February, 1991), and hepatitis B (July, 1992).
KoGENate (antihemophiliac factor)
Miles, Inc.Approved for use in the treatment of hemophilia A (February, 1993).
Leukine (yeast-derived GM-CSF)
Immunex Corp.Approved for use in autologous bone marrow transplantation (March, 1991).
Neupogen
Amgen Ltd.Approved for use in treating cheomtherapy-induced neutropenia (February, 1991) and bone marrow transplant-associated neutropenia (June, 1994).
Oncaspar (pegaspargase)
Enzone/Rhone-Poulenc RorerApproved for use in treating acute lymphoblastic leukemia (February, 1994).
Orthoclone OKT 3
Ortho BiotechApproved for use in reversal of acute kidney transplant rejection (June, 1986).
Procrit (epoetin alfa)
Ortho BiotechApproved for use in the treatment of anemia associated with chronic renal failure (December, 1990) and anemia in Retrovir-treated, HIV-infected patients and chemotherapy-associated anemia (April, 1993).
Proleukin, IL-2
Chiron Corp.Approved for the treatment of kidney (renal) carcinoma (May, 1992).
Protropin (somatrem)
Genentech, Inc.Approved for treating human growth hormone deficiency in children (May, 1985).
Pulmozyme (DNase)
Genentech, Inc.Approved for use in the management of cystic fibrosis (December, 1993).
Recombinate rAHF (recombinant antihemophiliac factor)
Baxter HealthcareRecombinate rAHF is the recombinant version of blood clotting factor VIII, and it has been approved for the treatment of hemophilia A (December, 1992).
Recombivax HB
Merck & Co.Approved as a hepatitis B prevention vaccine (July, 1986).
Roferon-A (recombinant alfa-interferon)
Hoffman-La RocheApproved for the treatment of hairy cell leukemia (June, 1986) and AIDS-related Kaposi's sarcoma (November, 1988