New Drug Approvals Archive

Exelon (rivastigmine)

New Dosage Form Approved: July 6, 2007

• Exelon Patch, the First and Only Skin Patch for the Treatment of Alzheimer's Disease, Receives First Worldwide Approval in US

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.

• FDA Approves Atralin Gel for Topical Treatment of Acne Vulgaris

Atralin (tretinoin) FDA Approval History

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.

• CSL Behring Announces FDA Approval of Privigen-- First Proline-Stabilized 10 Percent Liquid IVIg

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

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.

• FDA Approves CaloMist Nasal Spray for Vitamin B12 Deficiency

CaloMist (cyanocobalamin) FDA Approval History

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.

• KV Pharmaceutical Announces U.S. Food and Drug Administration Approval of EvaMist

EvaMist (estradiol) FDA Approval History

Privigen (immune globulin intravenous (human))

Labeling Revision Approved: April 19, 2010

• CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen from 24 to 36 Months

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