Humibid

Thread view:

Enable EMail Alerts

Start New Thread

Thread rating:

MS - 11 Nov 2004 17:17 GMT

Another article about it:

http://www.hsc.wvu.edu/sop/wvcdhi/Drug%20Related%20News/guaifenesin_availability.htm

or

http://tinyurl.com/6jv2w

It appears that Humibid L.A. is available again, but they have changed the
formulation to include another ingredient besides guaifenesin, potassium
guaiacolsulfonate. (No idea what that second ingredient does, but with the
guai in the name, I suspect it's similar.)

Anyone here taken this new version? Efficacy?

Reply to this Message

Don Brady - 11 Nov 2004 17:29 GMT

>Another article about it:
>
[quoted text clipped - 10 lines]
>
>Anyone here taken this new version? Efficacy?

Ah so they got around the FDA's prohibition of "single-ingredient guaifenesin"
by adding a nominal amount of a second ingredient!

Reply to this Message

Steven Litvintchouk - 12 Nov 2004 03:43 GMT

>>Another article about it:
>>
[quoted text clipped - 8 lines]
>>guaiacolsulfonate. (No idea what that second ingredient does, but with the
>>guai in the name, I suspect it's similar.)

Correct.

> Ah so they got around the FDA's prohibition of "single-ingredient guaifenesin"
> by adding a nominal amount of a second ingredient!

But then they fell right into the FDA's other trap. Adding a second
ingredient makes Humibid LA into a "new drug," meaning that the
manufacturer has to submit an application before the drug can be sold:

http://www.fda.gov/foi/warning_letters/g4569d.htm

Signature

Steven D. Litvintchouk
Email: sdlitvin@earthlinkNOSPAM.net

Remove the NOSPAM before replying to me.

Reply to this Message

MS - 13 Nov 2004 17:44 GMT

> But then they fell right into the FDA's other trap. Adding a second
> ingredient makes Humibid LA into a "new drug," meaning that the
> manufacturer has to submit an application before the drug can be sold:

I think it's been approved and is available.

I wonder if the new ingredient really adds any efficacy, or is only to get
it by the FDA.

Reply to this Message