New Drug Approvals Archive - August 2003
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August 2003
| August 12 |
Crestor (rosuvastatin calcium) Tablets Date of Approval: August 12, 2003
Company: AstraZeneca
Treatment for: Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, Hypertriglyceridemia, Dyslipidemia, Prevention of Cardiovascular Disease
Crestor is an 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 is also indicated for the primary prevention of cardiovascular disease. |
| August 19 |
Levitra (vardenafil hydrochloride) Tablets Date of Approval: August 19, 2003
Company: Bayer Corporation
Treatment for: Erectile Dysfunction
Levitra is a phosphodiesterase type 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. |
| August 27 |
Gamunex (immune globulin intravenous (human)) Injection 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). |
| November 9 |
Crestor (rosuvastatin calcium)
New Indication Approved: November 8, 2007
|
| September 15 |
Gamunex (immune globulin intravenous (human))
New Indication Approved: September 12, 2008
|
| November 6 |
Crestor (rosuvastatin calcium)
New Indication Approved: November 6, 2008
|
| October 16 |
Crestor (rosuvastatin calcium)
Patient Population Altered: October 15, 2009
|
| February 9 |
Crestor (rosuvastatin calcium)
New Indication Approved: February 8, 2010
|
New Drug Approvals Archive
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