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All The News Re The Loss of LA Guai
& What Might Come Next.
Created April 3, 2004
- Last revised: March 16, 2005
PROTEST CLOSED
April 10, 2004: The
time for the protest has passed.
There may be other things that arise in the future that we can do but for now
this issue is closed. The history of
the official Guai-Support Group Network
Protest Strategies can be found by
clicking here.
GG Management March 16, 2005:
"Given the doubts about the
future of Humibid, since the deal between Adams & Cornerstone became known, we
believe there is a high risk that Adams will withdraw the product to bolster
sales of Mucinex. We are well aware that Mucinex is unsatisfactory for many and
that others have an ‘in principle’ objection to supporting the company, due to
the unacceptable practices they used to gain a monopoly on LA guai.
There is no timeline on this, of course, but those members who find Humibid
successful may want to consider stocking up in preparation for a potential
withdrawal. This will provide the opportunity to take your time about finding a
suitable replacement product, should the anticipated ‘worst’ occur. "
(GG archives, March
16, 2005)
News Release: February 15, 2005
"Cornerstone BioPharma, Inc. and Adams Laboratories,
Inc., Enter Product Transfer Agreement
CARY, N.C., Feb. 15 -- Cornerstone BioPharma, Inc., the Triangle-based specialty
pharmaceutical company currently focused on the development and
commercialization of niche prescription medications in the pain, anti-infective,
and respiratory markets, and Adams Laboratories, Inc., a Chester, New
Jersey-based pharmaceutical company, have announced a business transaction
surrounding the AlleRx(TM) and Humibid(TM) family of products."
http://www.salesandmarketingnetwork.com/news_release.php?ID=2003324
http://biz.yahoo.com/prnews/050215/cltu051_1.html
http://www.cornerstonebiopharma.com/
http://www.adamslaboratories.com/
This impacts in 2 ways:
1.
What will happen to the Humibid E (which is manufactured by PharmaFab), and 2.
What will happen to the plans for an LA version of Guai that Cornerstone and
their contacts were considering.
We've had news from our industry contact
that there should be enough Humibid E (400mg QA) in the market place for now and
that either Adams will market under the Humibid name (which they own) or it will
be marketed by a new company under another name.
I've also heard back from Cornerstone and they are unable to proceed with the LA
version they'd planned, due to circumstances genuinely beyond their control.
However, they affirm that there others working on getting an LA version onto the
market and that they will ask them to contact me.
News: February 4, 2005
An application for pure LA guaifenesin has been submitted to the FDA. Perhaps it
will be out in less than a year. FDA approval for LA guaifenesin requires only
proof of stable delivery of the inherent drug. No safety studies are required
for guaifenesin. Just the manufacturing process. While the new LA will be
labeled Humibid, it will be made identical to the previous LA URL guaifenesin.
News: September 16,
2004:
Cornerstone
BioPharma, Inc.
purchased the Humibid Trade marks
from Carolina Pharmaceuticals. They began selling Humibid E 400mg QA in
October 2004 and have begun work on getting an LA product onto the market.
April, 2004:
Humibid LA 600-300mg, 12
Hour, Controlled Release Tablets
are
no longer available due to Adams Labs petitioning the FDA to remove it. They
insisted it was a single ingredient guaifenesin product that legally required an
NDA and the FDA went along with it.
Every
store in the US now has Mucinex on the shelves instead of hidden in the
pharmacy. Our
industry source
has advised us that an application for pure LA guai has been
submitted to the FDA. Perhaps it will be out
in less than a year but that's only a guess.
FDA approval for LA guaifenesin requires only proof of stable
delivery of the inherent drug. No safety studies
are required for guaifenesin. Just the
manufacturing process. While the new LA will be labeled Humibid, it will be made
identical to the previous LA URL guaifenesin.
News: March 12,
2004:
The manufacturers of Humibid LA
and DM, Carolina Pharmaceuticals, have been sent a
letter by the FDA informing them that they are in non-compliance
regarding NDA for both Humibid LA & DM.
These products are categorized as new drugs due to the inclusion of
potassium guaiacolsulfonate and therefore they
have been requested to immediately correct these
violations. In effect they are no longer permitted to market these
versions of Guaifenesin. Please
click on this link for further information
News: January 22, 2004
INC Magazine online:
Letter to President Bush re Guaifenesin from Darlene M. Ryan, President
& CE, PharmaFab, Grand Prairie, Texas
News:
November 4, 2003
Update on Adams Labs by GG Protest
Team Representative
Adams' Labs Announcements
(from
July 15, 2002 through to August 11, 2003)
Adams Laboratories Announces FDA Approval Of NDA For 1200 Mg Mucinex™ Tablet
Due to Adams' patent
on their combined long-acting,
regular-release (QA) combination product, the
FDA orders most long-acting guaifenesin
products off market.
The only approval, issued in July 2002, is
for guaifenesin 600 mg extended-release tablets from Adams Laboratories; other manufacturers have
until the end of November to distribute 'illegal' products thus most of the long-acting forms of
guaifenesin still listed here are no longer available, or stocks are lowering.
As information arrives and time permits I'll continue editing this page.
October 19, 2003 FDA News:
FDA Proposes Steps to Assure the Safety and Efficacy of Certain Currently
Unapproved Medicines: "...the Agency was aware of evidence that
certain extended-release guaiafenesin products were not released in the body at
the appropriate rate for an extended-release product, indicating that consumers
who purchased the products may not be receiving the benefits claimed."
Guai-Support is in the process of
mounting a 'multi-pronged' protest,
including (at this stage) a petition to Congress, personal stories/letters, FDA
Proposal responses, letters to FrontLine & MSNBC, our legal representation, our participation in the
network of key industry stakeholders, etc.
Click here read about, and participate, in these measures. For those
who find their part too daunting to do alone, please contact the
Protest Team for assistance at
GGProtestTeam@hotmail.com
You can
write to
manufacturers of Guai
to encourage them to
pursue the necessary testing and paperwork with the FDA to continue to
manufacture guaifenesin.
Sample Letter To Manufacturers
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