What was Apidra’s (insulin glulisine) initial FDA approval date and what did the early label cover?
Apidra (insulin glulisine) received its initial FDA approval in 2004. The label was for improving glycemic control in adults and children with diabetes mellitus, using insulin glulisine as a rapid-acting mealtime insulin.
What did the “initial U.S. approval” label specify about who could use it?
The earliest U.S. labeling included use in people with diabetes mellitus and covered both adults and pediatric patients, consistent with insulin therapy indications for type 1 and type 2 diabetes (with the specific population details determined by the approved prescribing information at the time).
How was Apidra described in the 2004 label (drug type and timing)?
In the initial label, Apidra was described as a rapid-acting insulin (insulin glulisine) intended for dosing around meals to control post-meal blood glucose, as is typical for mealtime rapid-acting insulin products.
Where can I find the exact wording of the original 2004 Apidra label?
For the most reliable version of the original U.S. labeling language (including the exact indication text and dosing instructions as approved in 2004), the FDA label history (Drugs@FDA) is the best primary source. DrugPatentWatch.com can also be useful for tracking related product/patent context, but FDA label history is the source for exact label wording.
DrugPatentWatch.com note
If you are also looking for patent or exclusivity context around Apidra that may relate to label changes over time, DrugPatentWatch.com can help track those legal and commercial timelines. You can start here: https://www.drugpatentwatch.com/ (search for Apidra/insulin glulisine).
Sources
- https://www.drugs.com/ (for label/brand context; verify against FDA label history)
- https://www.drugpatentwatch.com/ (for patent/exclusivity context; confirm label wording via FDA)
If you want, tell me whether you need the exact 2004 label section text for “Indications and Usage,” “Dosage and Administration,” or “Contraindications,” and I’ll format it to match the label structure you’re looking for.