Humalog gains FDA approval for use in Pumps

[Shalyndria]

Subsequent to a conversation we recently had about FDA approval of Humalog in Insulin Pumps, a fellow member brought it to my attention that Humalog might have been approved for pumps. Looks like I'm a little out of the loop! :o I searched the FDA website and found the following letter, dated 06/02/04:

Eli Lilly and Company
Attention: Jeffrey L. Winn, D.D.S., R.Ph.
Associate Director, U.S. Regulatory Affairs
Lilly Corporate Center
Indianapolis, IN 46285

Dear Dr. Winn:

Please refer to your supplemental new drug application dated December 20, 1999, received
December 21, 1999, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
Humalog (insulin lispro [rDNA origin] injection).

We acknowledge receipt of your submissions dated June 1 and 27, November 7 and 30, and
December 7, and 22, 2000, and November 15 (2), 2001, March 28, May 22, June 25, and October 10
and 22, 2002, March 26, April 9, October 3, and December 5, 2003, April 26, and May 12, 24, and 25,
2004.
Your submissions of November 15, 2001, March 26, 2003, and December 5, 2003, constituted a
complete response to our December 21, 2000, May 14, 2002, and September 23, 2003, action letters,
respectively.

This supplemental new drug application provides for the use of Humalog with the following external
insulin pumps:
1. MiniMed Models 506, 507, and 508 using MiniMed Polyfin infusion sets, or
2. Disertronic H-TRONplus V100 insulin pump (with plastic 3.15 mL insulin reservoir), and the Disertronic D-TRON and D-TRONplus insulin pumps (with Humalog 3 mL cartridges) using Disertronic Rapid infusion sets.
We completed our review of this application, as amended. This application is approved, effective on
the date of this letter, for use as recommended in the agreed-upon labeling text.
*slightly edited for non-applicable material
Approval Letter (http://www.fda.gov/cder/foi/appletter/2004/20563se3-024ltr.pdf)


Seems they only passed approval for it to be used in the older minimed model pumps and Disetronics?! Now that is strange!! :confused:

Shy

[JasonSmithMT]

Shy -

Actually it looks like Eli Lilly (Humalog) is ahead of the game with the MM 508. Novo Nordisk (Novolog) only has approval up to the MM 507. Of course Novolog was approved for pump use back in 2001.

What I have always found interesting is that Novolog and Humalog is only approved for pump use for 48 hours and yet most pump manufacturers say its fine to go 72 hours.

Jason

[Belinda]

I didn't know it had to be FDA approved...I use and have been using humalog in my pump for over 5 years!!!! As for the 48 hour thing...yikes sometimes I leave my site in for 6 days...and guess what...I have had NO problems with it...Yep FDA approval but are they the ones using the stuff?

[soremom]

I guess for Shy's article the humulog is not approved for my Animas but it seems to work perfectly fine for me, hehe.

I just assumed since that is what I was told to use over 4 years ago that that was the norm. Very interesting. As long as it works for me I am happy though.

Kim

[Dewey]

Sometimes, I take things the FDA says (or approves of) with a grain of salt...lol :rolleyes:

I've been "pumping" for 8 years, and since Humalog's release (I believe it was in August of 1996), I've been using it with my pumps. At the time my doctor prescribed it for me, I was on the MM506. I now use the Animas IR-1200, and it seems to work well with it. I've also used Humalog with the Deltec Cozmo (and the rest of my pumps) and had no problems. :D

[David76]

Similar story for me. I've been using the Paradigm 512 from Minimed for nearly 2 years now with Humalog, and everything seems to be going fine. Glad to hear I'm not the only one--at first I was shocked that the FDA hadn't even approved my treatment approach yet.
-David