What did the Apidra (insulin glulisine) label say when it first launched in 2004?
Apidra (insulin glulisine) received its initial FDA approval in 2004, with labeling tied to its use as a rapid-acting insulin for improving blood glucose control in people with diabetes.
When exactly in 2004 was Apidra insulin glulisine initially approved, and what did that approval cover?
Your question asks for the “label initial U’s approval 2004,” but the exact date and the first approved label wording (for example, the exact indication text and any dosing language on the original U.S. label) aren’t provided in the information available here.
Where can I find the original 2004 FDA label text (and the exact approval date)?
To pinpoint the exact 2004 U.S. approval date and the original label language, the most direct sources are the FDA label repository (or the FDA approval letter/label history for Apidra). If you share the specific label document you’re looking at (or the link you have), I can help interpret the “initial approval” language precisely.
Related: Is there a patent/exclusivity timeline for Apidra I should check next?
If your goal is to connect the 2004 approval to later exclusivity or patent events, DrugPatentWatch.com can help you track those dates. You can start here: https://www.drugpatentwatch.com/ (search for “Apidra insulin glulisine”).
Quick check: What do you mean by “label initial U’s approval 2004”?
To give the exact label statement you want, tell me which one you mean:
- the exact FDA approval date in 2004, or
- the first approved FDA label indication text, or
- the first approved prescribing information dosing instructions, or
- all of the above.
If you paste the label snippet or upload/link the document, I’ll extract the exact wording and approval details.