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New Drug Approvals Archive

New Drug Approvals: April 2004

April 7
Nasacort HFA (triamcinolone acetonide) Nasal Aerosol

Date of Approval: April 7, 2004

Company: Aventis Pharmaceuticals Inc.

Treatment for Allergic Rhinitis

Nasacort HFA is a dry-aerosol intranasal corticosteroid formulation containing hydrofluoroalkane (HFA). It replaces Nasacort Nasal Inhaler, which along with other nasal inhalers containing CFC’s, was taken off the market to comply with Environmental Protection Agency (EPA) and FDA requirements intended to protect the ozone layer. Nasacort HFA Nasal Aerosol is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children age 6 and older.

Nasacort HFA Aventis Pharmaceuticals Inc. - Treatment for Allergic Rhinitis
 
April 7
Ribasphere () Capsules

Company: Three Rivers Pharmaceuticals

Treatment for Hepatitis C (“HCV”)

Ribasphere Three Rivers Pharmaceuticals - Treatment for Hepatitis C (“HCV”)
 
April 9
ChiRhoStim (secretin synthetic human) - formerly Human Secretin

Date of Approval: April 9, 2004

Company: ChiRhoClin, Inc.

Treatment for Diagnostic

ChiRhoStim is indicated for use in diagnostic procedures.

Human Secretin ChiRhoClin, Inc. - Treatment for Secretin Stimulation Testing
 
April 16
Apidra (insulin glulisine) Injection

Date of Approval: April 16, 2004

Company: Aventis Pharmaceuticals Inc.

Treatment for Diabetes Mellitus Type I, Diabetes Mellitus Type II

Apidra is a recombinant DNA human insulin analogue that has a more rapid onset and a shorter duration of action than regular human insulin. Apidra is used for the control of hyperglycemia in adult patients with diabetes mellitus.

Apidra Aventis Pharmaceuticals Inc. - Treatment for Diabetes Mellitus
 
April 20
Apokyn (apomorphine) Injection

Date of Approval: April 20, 2004

Company: Bertek Pharmaceuticals

Treatment for Parkinson's Disease

Apokyn is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson’s disease.

Apokyn Bertek Pharmaceuticals - Treatment for Parkinson’s Disease
 
April 28
Fortamet (metformin) Extended-Release Tablets

Date of Approval: April 28, 2004

Company: Andrx Corporation

Treatment for Diabetes Mellitus Type II

Fortamet is an extended-release formulation of metformin that suppresses hepatic glucose production and improves peripheral insulin sensitivity. Fortamet is indicated as an adjunct to diet and exercise in order to lower blood glucose in patients with type 2 diabetes.

Fortamet Andrx Corporation - Treatment for Type 2 Diabetes
 
April 29
Mucinex DM () Extended Release Tablets

Company: Adams Respiratory Therapeutics

Treatment for Cough

Mucinex DM Adams Respiratory Therapeutics - Treatment for Cough
 

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