New Drug Approvals Archive - April 2004

Cardizem LA (diltiazem hydrochloride)

New Indication Approved: April 2, 2004

• FDA Approves Biovail's Cardizem LA for the Treatment of Angina

Nasacort (triamcinolone acetonide)

New Formulation Approved: April 7, 2004

• FDA Approves Nasacort HFA for Allergic Rhinitis

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 Three Rivers Pharmaceuticals - Treatment for Hepatitis C ("HCV")
• Ribasphere (ribavirin) FDA Approval History

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
• ChiRhoStim (secretin synthetic human) FDA Approval History

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 Aventis Pharmaceuticals Inc. - Treatment for Diabetes Mellitus
• Apidra (insulin glulisine) FDA Approval History

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 Bertek Pharmaceuticals - Treatment for Parkinson’s Disease
• Apokyn (apomorphine) FDA Approval History

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 Andrx Corporation - Treatment for Type 2 Diabetes
• Fortamet (metformin) FDA Approval History

Apidra (insulin glulisine)

New Dosage Regimen: April 12, 2007

• FDA Approves New Route of Administration for Rapid-Acting Apidra Providing an Additional Treatment Option for Hospitalized Diabetes Patients with High Blood Sugar Levels
• Apidra (insulin glulisine) FDA Approval History

Apidra (insulin glulisine)

Patient Population Altered: October 24, 2008

• FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes
• Apidra (insulin glulisine) FDA Approval History

Apidra (insulin glulisine)

New Dosage Form Approved: February 24, 2009

• FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen
• Apidra (insulin glulisine) FDA Approval History