New Drug Approvals Archive

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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, 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

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