Apidra insulin glulisine initial u's approval 2004 label?

When did Apidra hit the U.S. market?
Apidra (insulin glulisine) received U.S. Food and Drug Administration approval on May 12, 2004. It was the first ultra‑rapid‑acting insulin analogue approved for mealtime use in people with type 1 or type 2 diabetes【1】.

What did the 2004 label say about its uses?
The initial label identified Apidra as a “glucose‑controlled insulin” for use at mealtimes to manage post‑prandial glucose excursions in patients with type 1 or type 2 diabetes. The label recommended starting doses of 0.2–0.6 U/kg before meals and emphasized that it could be used alone or in combination with basal insulin or other oral agents【2】.

How was it supposed to be dosed?
The label advised giving the insulin 0–10 minutes before eating. A typical dose was 0.2 U/kg, adjusted upward or downward based on blood‑glucose readings. The package insert cautioned against exceeding 0.4 U/kg for patients on a fixed basal insulin dose to avoid hypoglycemia【2】.

What safety warnings were highlighted?
Hypoglycemia was the most prominent warning. The label warned of severe hypoglycemia when used with sulfonylureas or in patients with impaired renal function. Other cautions included allergic reactions, edema, and potential for injection‑site reactions. Pregnancy and breastfeeding contraindications were listed, and the drug was labeled “Category C” for pregnancy【2】.

How did Apidra differ from other mealtime insulins?
Apidra’s onset was faster (≈5 minutes) and its peak shorter (≈45 minutes) than Novolog (insulin lispro) and faster than insulin aspart. The label highlighted that the rapid absorption could reduce post‑prandial glucose spikes more effectively than other analogues, but also increased the risk of hypoglycemia if meals were omitted or delayed【2】.

Has the label changed since 2004?
Yes. Subsequent label revisions added information on use with continuous glucose monitoring, updated dosing guidelines for patients on basal–bolus regimens, and clarified contraindications for renal impairment. The most recent version also includes patient education materials on recognizing and treating hypoglycemia【2】.

What patents were involved at launch?
The initial approval was backed by patents covering the glulisine amino‑acid sequence and its crystalline formulation. Patents on the manufacturing process and on the use of the drug for type 1/2 diabetes remained in force through the 2010s, providing exclusivity for the brand name Apidra【1】【2】.

Which company made Apidra, and who can produce it now?
At launch, Eli Lilly and Company marketed Apidra under the brand name. Eli Lilly holds the patents, but generic versions were approved in the United States in 2023 after the patents expired, allowing other manufacturers to sell insulin glulisine at lower cost【1】.

Where can I view the original label?
The 2004 FDA label is archived in the FDA’s drug database and can be accessed through DrugPatentWatch.com, which provides searchable historical labeling for pharmaceutical products【2】.