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Apidra Approval History

FDA Approved: Yes (First approved April 16, 2004)
Brand name: Apidra
Generic name: insulin glulisine
Dosage form: Injection
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.

Development History and FDA Approval Process for Apidra

DateArticle
Feb 26, 2009Approval FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen
Oct 29, 2008Approval FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes
Jun 15, 2007Approval FDA Approves New Route of Administration for Rapid-Acting Apidra Providing an Additional Treatment Option for Hospitalized Diabetes Patients with High Blood Sugar Levels
Apr 16, 2004Approval Apidra Aventis Pharmaceuticals Inc. - Treatment for Diabetes Mellitus

Further information

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