New Drug Approvals Archive

New Drug Approvals: July 2007

July 9
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
 
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.

FDA Approves Atralin Gel for Topical Treatment of Acne Vulgaris
 
July 26
Privigen (Immune Globulin Intravenous (Human)) 10% Liquid

Date of Approval: July 26, 2007

Company: CSL Behring

Treatment for: Primary Immunodeficiency Syndrome, Idiopathic (Immune) Thrombocytopenic Purpura

Privigen is a ready-to-use 10 percent liquid preparation of polyvalent human immunoglobulin indicated for the treatment of patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.

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

FDA Approves CaloMist Nasal Spray for Vitamin B12 Deficiency
 
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.

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

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