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New Drug Approvals Archive - April 2004

April 2004

April 5

Cardizem LA (diltiazem hydrochloride)

New Indication Approved: April 2, 2004

April 7

Nasacort (triamcinolone acetonide)

New Formulation Approved: April 7, 2004

April 6

Ribasphere (ribavirin) Capsules

Date of Approval: April 6, 2004
Company: Three Rivers Pharmaceuticals, LLC
Treatment for: Chronic 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.

Ribasphere (ribavirin) FDA Approval History

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.

ChiRhoStim (secretin synthetic human) FDA Approval History

April 16

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.

Apidra (insulin glulisine) FDA Approval History

April 20

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.

Apokyn (apomorphine) FDA Approval History

April 28

Fortamet (metformin) Extended-Release Tablets

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

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

Fortamet (metformin) FDA Approval History

June 15

Apidra (insulin glulisine)

New Dosage Regimen: April 12, 2007

Apidra (insulin glulisine) FDA Approval History

October 29

Apidra (insulin glulisine)

Patient Population Altered: October 24, 2008

Apidra (insulin glulisine) FDA Approval History

February 26

Apidra (insulin glulisine)

New Dosage Form Approved: February 24, 2009

Apidra (insulin glulisine) FDA Approval History

New Drug Approvals Archive