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& What Might Come Next. PROTEST CLOSED April 10, 2004: The time for the protest has passed.
GG Management March 16, 2005:
"Cornerstone BioPharma, Inc. and Adams Laboratories,
Inc., Enter Product Transfer Agreement 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.
News: February 4, 2005
News: September 16,
2004:
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:
News: January 22, 2004
News:
November 4, 2003
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. |
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The information on this site is the property of the Guai-Support ListOwner Tesa Marcon:
vashtii@optusnet.com.au
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