New Drug Approvals Archive
New Drug Approvals: April 2004
| April 7 | Nasacort (triamcinolone acetonide)
New Formulation Approved: April 7, 2004 FDA Approves Nasacort HFA 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 rapid-acting recombinant DNA human insulin analogue used for the control of hyperglycemia in 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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