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[IP] fda apprfoval for pumping.

Jan <email @ redacted> wrote:

> Note, it said ""insulin analog." Nordisk's Velosulin is also the only
> approved insulin for use in pumps. People still use(d) Lilly Regular and I
> don't know why Nordisk can get approval and not Lilly (for R or Humalog).
> But as it has been stated on this list many times, what the physician Rx's
> for use is what is supposed to be honored. (~_^)

Perhaps it bears repeating that approval by the FDA has nothing to do with
how physicians prescribe and/or patients use a drug.  Approval has to do
with how a drug or device may be marketed and sold.  Up to now, the only
insulin approved by the FDA for use in insulin pumps is Velosulin by Novo.
I believe most people have been using Humalog in their pumps ever since it
came on the market.

Jim Handsfield
email @ redacted

FDA approval is a condiotion of the device or drug obtaining Medicare
coverage, Since all of us know how brilliant they are. Maybe Lilly didn't want
to go thru the approval for pump process since at the time Humulog made its
debut they were still selling BR "Buffered regular" which was specifically
approved for pumps by the FDA. Lilly has discontinued the sale of Buffered
regular although it can be obtained for compassionate use like all their
stuff, Even Animal Insulins and PZI spot
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