FDA Approves Updates to Lilly’s Humalog® (insulin lispro injection rDNA origin) Label

INDIANAPOLIS, June 8, 2011 /PRNewswire/ — Eli Lilly and Company
(NYSE:
LLY) today announced that the U.S. Food and Drug Administration
(FDA) approved the company’s supplemental new drug application
(sNDA) with the following updates to the Humalog label:

• continuous insulin infusion pump therapy in children 4 years of
  age and over with type 1 diabetes
• extension of the time-in-use in the external pump reservoir to
  a maximum of seven days; and
• extension of the time-in-use of the infusion set and of the
  infusion set subcutaneous insertion site to a maximum of three
  days.

Based on the updated label, people with type 1 diabetes using
Humalog for pump therapy can use the insulin in the pump reservoir
for up to seven days and should change the infusion set and
infusion set insertion site at least every three days. The previous
label indicated that Humalog in the external insulin pump reservoir
should be replaced and a new infusion site selected every 48 hours
or less.

Humalog, which contains 100 units per mL, is used to treat
people with diabetes for the control of high blood sugar. Humalog
should not be taken by someone with low blood sugar (hypoglycemia)
or by someone who is allergic to insulin lispro or any of the
ingredients in Humalog. Humalog is recommended for use in pump
systems indicated for continuous delivery of fast-acting insulin.
All people treated with insulin should closely monitor their blood
glucose and make changes to their insulin regimen cautiously and
only under medical supervision. See Important Safety Information
below, and additional information about Humalog is available at www.humalog.com.

Insulin pumps deliver insulin 24 hours a day through a catheter
placed under the skin. Rapid-acting insulin is delivered
continuously to help keep blood

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