I just got a refill for Mucofen 1000SA by Wakefield. My doc didn't seem to
know any different. I'll check with my pharmacist. I never seemed to do much
for me anyway and too long ingestion seemed to give me indigestion.
Don Brady ***@pobox.com wrote:
<< This one is more up to date:
http://www.af-pharmacists.org/safp/publications/recalls/mmqc_02_1351.htm
or
http://www.adamslaboratories.com/PRESS%20RELEASE%2010-21-02.pdf
Note the sentence:
"the FDA issued warning letters on October 11, 2002, deeming all extended
release guaifenesin tablets without an approved abbreviated new drug
application (ANDA) or NDA illegal and misbranded."
==================================================================
Adams Respiratory Therapeutics ANNOUNCES FDA APPROVAL OF NDA FOR 1200 mg
MUCINEX™ TABLET
- FDA Action Marks Company’s Second Product Approval for Long-Acting
Guaifenesin -
Fort Worth, TX – January 21, 2003 – Adams Respiratory Therapeutics, Inc., a
provider of specialty pharmaceuticals for respiratory care, today announced it
has received approval from the U.S. Food and Drug Administration (FDA) for its
new drug application (NDA) for the 1200 mg strength tablet of Mucinex™, a
single-entity, long-acting guaifenesin product that will be available without a
prescription. Mucinex™ provides the maximum therapeutic daily dosage of
guaifenesin for adults by taking one 1200 mg tablet, or two 600 mg tablets,
every 12 hours. It is indicated to help loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus and
make coughs more productive.
The FDA approval of Mucinex™ 1200 mg is Adams Laboratories’ second product
approval in six months. In July of last year, the FDA approved the company’s
NDA for the Mucinex™ 600 mg tablet - the first long-acting guaifenesin
product
to have an NDA approved by the FDA. As a result of the Durham-Humphrey
Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act which stipulates
that a drug product cannot be marketed simultaneously both as a prescription
and as a nonprescription product at the same strength and same dosage and for
the same indication, the FDA issued warning letters on October 11, 2002,
deeming all extended release guaifenesin tablets without an approved
abbreviated new drug application (ANDA) or NDA illegal and misbranded.
John Q. Adams Sr., Chairman and Chief Executive Officer, stated, “The FDA
approval of our Mucinex™ 1200 mg tablet marks Adams Respiratory
Therapeutics’
second major drug approval in the past several months, and demonstrates the
company’s ability to leverage our unique regulatory strategy and proprietary
technology to build a strong pipeline of respiratory products. Our large,
knowledgeable sales force will continue to aggressively market both the 600 mg
and 1200 mg Mucinex™ tablets to physicians and pharmacists in order to
capture
as much of the $3.2 billion cough, cold and flu market as possible. In
addition, we will continue to expand our respiratory franchise with NDA
submissions for Mucinex™ combination products this year.”
Mucinex™ is available “behind the counter” from pharmacists nationwide,
with or
without a physician’s recommendation. It works by loosening phlegm (mucus)
and
thinning bronchial secretions to rid the bronchial passageways of bothersome
mucus – making coughs more productive. Mucinex™ combines extended-release
and
immediate-release features in a single tablet.
ABOUT Adams Respiratory Therapeutics:
Based in Fort Worth, Texas, Adams Respiratory Therapeutics develops, markets
and sells prescription and non-prescription pharmaceuticals for the treatment
of respiratory disorders and diseases. In addition to Mucinex™, the Adams
Respiratory Therapeutics product portfolio includes the Aquatab® line of
guaifenesin-based cough and cold products and the ALLERx™ line of products to
treat allergic rhinitis. Adams Laboratories seeks to become the leading
specialty provider of pharmaceuticals for the treatment of a broad range of
respiratory diseases via a business development strategy that combines product
development, acquisitions and in-licensing tactics. More information can be
found on the company’s website at www.adamslaboratories.com. >><BR><BR>
Sue M.