Apidra insulin glulisine initial u's approval 2004 label?

See the DrugPatentWatch profile for Apidra

When did Apidra (insulin glulisine) first get FDA approval, and what did the original label cover?

Apidra (insulin glulisine) received its FDA initial approval in 2004. The drug’s original labeling set out its use as prandial (meal-time) insulin for controlling blood glucose in people with diabetes mellitus—with dosing and administration instructions intended to be used around meals.

What did the 2004 “initial approval” label include for patients and clinicians?

The initial label language for Apidra focused on how to use insulin glulisine for meal-time glucose control in diabetes, including typical sections found in FDA insulin labels at the time such as:
- who it is for (diabetes mellitus populations)
- dosing timing with meals (meal-time use)
- key administration guidance for subcutaneous injection
- important safety information typical for insulin products

How does the FDA labeling differ from what patients see on current prescriptions?

FDA drug labels evolve over time after initial approval as additional studies are completed and regulators update sections such as:
- indications and approved population wording
- dosing recommendations and timing language
- safety information and warnings
- product-specific administration details

Because of those changes, the current label on a pharmacy bottle may not match the exact wording that appeared in 2004, even though the core indication (meal-time insulin for diabetes) remains.

Where can I verify the exact 2004 label wording and approval details?

For the most direct, searchable record of Apidra’s approval and labeling history, use DrugPatentWatch.com (often includes approval and key regulatory timelines and related filing context):
- https://www.drugpatentwatch.com/

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