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New Drug Approvals Archive

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July 2007

July 9

Exelon (rivastigmine)

New Dosage Form Approved: July 6, 2007

July 26

Atralin (tretinoin) Gel

Date of Approval: July 26, 2007
Company: Coria Laboratories, Ltd.
Treatment for: Acne

Atralin (tretinoin) gel is a retinoid indicated for topical treatment of acne vulgaris.

Atralin (tretinoin) FDA Approval History

July 26

Privigen (immune globulin intravenous (human)) Liquid

Date of Approval: July 26, 2007
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome, Idiopathic (Immune) Thrombocytopenic Purpura

Privigen is an immune globulin intravenous (human), 10% liquid indicated for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

Privigen (immune globulin intravenous (human)) FDA Approval History

July 27

CaloMist (cyanocobalamin) Nasal Spray

Date of Approval: July 27, 2007
Company: Fleming & Company, Pharmaceuticals
Treatment for: Vitamin B12 Deficiency

CaloMist is a nasal spray formulation of cyanocobalamin indicated for the maintenance of vitamin B12 concentrations in patients with vitamin B12 deficiency who have been normalized with intramuscular vitamin B12 therapy.

CaloMist (cyanocobalamin) FDA Approval History

July 27

EvaMist (estradiol) Transdermal Spray

Date of Approval: July 27, 2007
Company: VIVUS, Inc.
Treatment for: Postmenopausal Symptoms

EvaMist is an estradiol transdermal spray administered once daily for the treatment of vasomotor symptoms (hot flashes) associated with menopause.

EvaMist (estradiol) FDA Approval History

April 19

Privigen (immune globulin intravenous (human))

Labeling Revision Approved: April 19, 2010

Privigen (immune globulin intravenous (human)) FDA Approval History

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