New Drug Approvals Archive
New Drug Approvals: August 2003
| August 13 | Crestor (rosuvastatin calcium) Date of Approval: August 12, 2003 Company: AstraZeneca Treatment for Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, Hypertriglyceridemia Crestor is a HMG-CoA reductase inhibitor approved as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. Crestor AstraZeneca - Treatment for Hypercholesterolemia |
| August 19 | Levitra (vardenafil hydrochloride) Date of Approval: August 19, 2003 Company: Bayer Corporation Treatment for Erectile Dysfunction Levitra is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) indicated for the treatment of erectile dysfunction. Levitra Bayer Corporation - Treatment for Erectile Dysfunction |
| August 27 | Gamunex (immune globulin intravenous (human)) Date of Approval: August 27, 2003 Company: Bayer Corporation Treatment for Primary Immunodeficiency Syndrome, Idiopathic (Immune) Thrombocytopenic Purpura, Chronic Inflammatory Demyelinating Polyradiculoneuropathy Gamunex (immune globulin intravenous (human)) is indicated for the treatment of primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy (CIDP). FDA Approves Gamunex for Primary Humoral Immunodeficiency and Idiopathic Thrombocytopenic Purpura |
| August 28 | Wellbutrin XL () Extended-Release Tablets Company: GlaxoSmithKline Treatment for Depression Wellbutrin XL GlaxoSmithKline - Treatment for Depression |
| August 29 | Wellbutrin XL () Extended-Release Tablets Company: GlaxoSmithKline Treatment for Depression Wellbutrin XL GlaxoSmithKline - Treatment for Major Depressive Disorder |
New Drug Approvals Archive
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