What does “Apidra initial U.S. approval (2004) label” refer to?
Apidra is the brand name for insulin glulisine. Its initial U.S. approval in 2004 corresponds to the first FDA-approved prescribing information (the “label”) for insulin glulisine, including the drug’s approved indications, key dosing instructions, contraindications, and boxed or major safety information as published by the FDA at the time.
What was Apidra’s FDA-approved use when first labeled in 2004?
The 2004 U.S. label would specify Apidra’s indicated use (for example, as an insulin for improving glycemic control in patients with diabetes mellitus), along with any age range and whether it was intended for adults, children, or both—language that can differ across label revisions.
What dosing and administration terms are usually on the 2004 Apidra label?
Early FDA labels for insulin products typically include:
- How to administer insulin glulisine (subcutaneous injection; and whether it was approved for any infusion route in that initial labeling)
- Pre-meal timing guidance (insulin glulisine is generally dosed around meals)
- Important safety instructions for insulin use, including hypoglycemia risk and glucose monitoring expectations
Exact wording for the “initial” 2004 label depends on the specific version of the FDA-approved package insert being referenced.
Why might the 2004 Apidra label you see differ from later labels?
FDA labels change over time due to:
- New clinical data (for dosing, patient populations, or administration methods)
- Safety updates
- Label formatting and risk communication changes
- Changes driven by postmarketing experience or regulatory updates
So “2004 initial approval label” usually means you want the earliest FDA-approved package insert for insulin glulisine, not a later revision.
How can you confirm the exact 2004 label text you need?
To pull the precise 2004 label (the exact indication and dosing wording), you need one of the following:
- The specific FDA label document/version (package insert date)
- A link or the text/photo of the label you’re looking at
- The approval letter/date or label reference you mean by “initial”
If you share the label link or a screenshot (or tell me the label date/version shown on the document), I can extract the exact “initial U.S. approval 2004” labeled indication and dosing language from it.
Sources
No sources were provided in your message, and I don’t have access to the Apidra 2004 FDA label text from the prompt alone. If you paste the label link or content, I can cite it accurately.