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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