New Drug Approvals Archive

Crestor (rosuvastatin calcium) Tablets

Date of Approval: August 12, 2003
Company: AstraZeneca
Treatment for: Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, Hypertriglyceridemia, 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.

• Crestor AstraZeneca - Treatment for Hypercholesterolemia

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.

• Levitra Bayer Corporation - Treatment for Erectile Dysfunction

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).

• FDA Approves Gamunex for Primary Humoral Immunodeficiency and Idiopathic Thrombocytopenic Purpura

Crestor (rosuvastatin calcium)

New Indication Approved: November 8, 2007

• Crestor Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol

Gamunex (immune globulin intravenous (human))

New Indication Approved: September 12, 2008

• FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States

Crestor (rosuvastatin calcium)

New Indication Approved: November 6, 2008

• Crestor Approved for Primary Dysbetalipoproteinemia

Crestor (rosuvastatin calcium)

Patient Population Altered: October 15, 2009

• U.S. Food and Drug Administration Approves Crestor for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

Crestor (rosuvastatin calcium)

New Indication Approved: February 8, 2010

• FDA Approves Crestor to Reduce Stroke, Heart Attack Risk