What year was Guaifenesin sustained release products introduced into
the U.S. market?

---

Request for Question Clarification by nocky-ga on 26 Dec 2002 07:59 PST

Hi.
If you are referring to the FDA approved "Mucinex," a twelve-hour
version of guaifensin, then I think I have your answer. Please let me
know,
Thanks

Hi Pyramids,

The FDA had been sending out warning letters dated October 11, 2002
about Guaifenesin sustained release products .

Here is a short exceprt of the letter:

“However, on July 12, 2002, FDA approved NDA 21-282 covering the
marketing of Mucinex 600 mg, a guaifenesin extended release tablet
expectorant for patients 12 years and above.

Other single ingredient extended release guaifenesin drug products,
which are new drugs, must be approved under an NDA or abbreviated new
drug application (ANDA) as required by the Federal Food, Drug, and
Cosmetic Act (the Act). There are no approved applications under the
provisions of Section 505 on file with the FDA for the previously
listed products marketed by your firm.

Therefore, the marketing of these products without an approved new
drug application constitutes a violation of Section 505(a) of the
Act.”
Source: FDA Website
http://www.fda.gov/foi/warning_letters/g3624d.pdf

You can read all the warning letters from here:
http://63.75.126.224/Google/fda_search.pl?q=Guaifenesin+was+approved&client=fdagov&site=fdagov&searchselector=&restrict=&sa=Search&filter=0&start=0

If this information answers your question, please let me know.

Thanks
--Bobbie7-ga (Google Answers Researcher)

This does not answer my question...I need to know the year the first
Sustained Release Guaifenesin product was introduced

The Mucinex was simply a new approved use.

Entex-LA has been around for a long time: it contains 600mg of
sustained release guaifenesin. There must be earlier brand name drugs
like it.

Guaifenesin was approved in 1952, but I don't know when the SR version
was approved.

hlabadie-ga

Looking for FDA approval information is not going to produce an
answer:

"The newly FDA approved cough and cold product, Mucinex (guaifenesin
600 mg. tablets), may change the regulatory requirements for all
single-ingredient products containing guaifenesin (such as
Robitussin). Mucinex is the first single-ingredient guaifenesin
product to obtain FDA approval. All other single-ingredient
guaifenesin products currently on the market, both Rx and OTC, do not
have FDA approval because guaifenesin is old enough to have been
"grandfathered" onto the market since the drug was in use prior to the
FDA’s New Drug Application regulations."
Google cache: http://216.239.53.100/search?q=cache:MkRuu1PlQfgC:www.nacds.org/wmspage.cfm%3Fparm1%3D538+FDA+approval+guaifenesin&hl=en&ie=UTF-8