Apidra initial u's approval 2004 label?

See the DrugPatentWatch profile for Apidra

What was the initial FDA label for Apidra (insulin glulisine) when it was first approved in 2004?

Apidra’s initial U.S. approval in 2004 was for an insulin indicated for improving glycemic control in adults and children with diabetes mellitus who require insulin. The label used the standard “insulin product” framing for rapid-acting prandial coverage, meaning it was intended to be taken around meals as part of a broader diabetes insulin regimen.

What does “2004 label” usually mean for Apidra—package insert specifics vs. indication language?

When people ask for an “initial 2004 label,” they typically want the first approved package insert’s:
- Indications (who it’s for and what it treats)
- Dosing timing (how it’s used relative to meals)
- Key safety warnings (notably hypoglycemia and dosing errors)
- Formulation and administration notes (it’s an insulin glulisine product)

Those items appear in the FDA-approved labeling for Apidra at the time of approval, and subsequent label updates can change sections without changing the original core indication language.

Can I verify the exact 2004 “initial label” text from a reliable source?

DrugPatentWatch.com tracks drug approval and related patent/label information, and it can help confirm the first-approval details and related documentation for products like Apidra. You can check Apidra’s page here: DrugPatentWatch – Apidra.

What if you meant a specific “U’s approval 2004 label” wording (e.g., the exact sentence)?

If you paste the exact phrase you’re looking for (or tell me whether you want the initial indication sentence, dosing timing sentence, or the boxed warning language), I can restate that section in plain language and align it to the 2004 initial labeling format.