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New Drug Approvals Archive - April 2004

See also: New Indications and Dosage Forms for April 2004

April 2004

Ribasphere (ribavirin) Capsules

Date of Approval: April 6, 2004
Company: Three Rivers Pharmaceuticals, LLC
Treatment for: Hepatitis C

Ribasphere (ribavirin) is a nucleoside analogue indicated in combination with peginterferon alfa-2a for the treatment of adults with chronic hepatitis C virus infection.

ChiRhoStim (secretin synthetic human) - formerly Human Secretin

Date of Approval: April 9, 2004
Company: ChiRhoClin, Inc.
Treatment for: Diagnosis and Investigation

ChiRhoStim is indicated for use in diagnostic procedures.

Apidra (insulin glulisine) Injection

Date of Approval: April 16, 2004
Company: Aventis Pharmaceuticals Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Apidra (insulin glulisine) is a rapid-acting recombinant DNA human insulin analogue used for the control of hyperglycemia in patients with diabetes mellitus.

Apokyn (apomorphine) Injection

Date of Approval: April 20, 2004
Company: Bertek Pharmaceuticals
Treatment for: Parkinson's Disease

Apokyn (apomorphine) 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.

Fortamet (metformin) Extended-Release Tablets

Date of Approval: April 28, 2004
Company: Andrx Corporation
Treatment for: Diabetes, Type 2

Marketing Status: Discontinued.

Fortamet (metformin) is an extended-release antihyperglycemic for the treatment of type 2 diabetes.

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