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Question:

Please advise if Humalog has been approved in the US. Should a 10 year old using regular and NPH switch the regular to Humalog?

Answer:

Humalog® (Eli Lilly's brand name for its new product, insulin lispro) received preliminary approval by the Endocrine and Metabolic Drug Advisory Committee of the U.S. Food and Drug Administration in February, 1996. It is anticipated that it should probably receive final approval at an upcoming FDA meeting, perhaps this month (the month of May, 1996).

It is our understanding that Humalog has not had adequate studies done in children or in pregnant women to be sure of its safety in these patients, and the labeling will most likely indicate something to that effect.

We really don't know whether it would be wise to automatically switch anybody to this product. We anticipate trying it in our diabetes programs, with very close followup and tremendous amounts of patient education explaining how it differs from Regular insulin.

If your child is in a pediatric diabetes program that will be trying the product, go ahead and partipate fully with the program's plans. However, we would presently advise that all people with diabetes consult a knowledgeable endocrinologist before deciding whether to switch from Regular to Humalog.

WWQ
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Additional Note (June, 1996)

Humalog® (insulin lispro) has received final approval from the U.S. Food and Drug Administration in June, 1996. It is anticipated that it should become available in the U.S. by autumn, 1996.

Additional Note (August, 1996)

Humalog® (insulin lispro) is now available in the U.S., as of mid-August, 1996.

Original posting 16 May 96

  
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Last Updated: Tuesday April 06, 2010 15:08:52
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