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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