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RE: [IP] Humalog

> >Humalog was NEVER approved for the pump?
> I read that it hadn't been approved for use in a pump but that is a
> technical matter and it may have been on a website that wasn't
> updated. I'm sure Lilly would know but it's still a technical matter
> because it's been used for quite some time.

Approval for a drug by the FDA is an indication that the company may 
MARKET the drug for certain purposes. E.Lilly simply does not have 
approval to say "it's ok to use Humalog in an insulin pump". This 
says absolutely nothing about the efficacy of Humalog for pump use. 
The necessary studies were done to assure the Humalog is safe for use 
in humans. 

The flip side of that is that Novo Nordisk has done studies to show 
the efficacy of both Novolog and Velosulin for human use in pumps and 
they have FDA approved to say so in their marketing literature. This 
is over and above the studies required to show that those products 
are safe for general use in humans.

The way the system works, any drug that is approved for use by the 
FDA may be used (prescribed) for any "off label" use that a physician 
sees fit.

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