SILVER SPRING, Md., March 2, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration today took action against
companies that manufacture, distribute, or market certain
unapproved prescription oral cough, cold, and allergy products. The
affected products cannot be legally marketed in the United
States.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
Unapproved prescription cough, cold, and allergy drug products
have not been evaluated by the FDA for safety, effectiveness, and
quality. People may be at greater risk when using these products
than when using FDA-approved prescription drugs or drugs that are
appropriately marketed over-the-counter (OTC).
Many health care providers are unaware of the unapproved status
of drugs and have continued to unknowingly prescribe them because
the drugs’ labels do not disclose that they lack FDA approval.
“Removing these unapproved products from the market will reduce
potential risks to consumers,” said Deborah Autor, director of the
Office of Compliance in the FDA’s Center for Drug Evaluation and
Research. “There are many FDA-approved prescription products,
as well as appropriately marketed over-the-counter products,
available to treat cough, cold, and allergy symptoms; so, we expect
little or no negative impact on consumers from the removal of these
unapproved products.”
Companies that have previously listed products subject to
today’s action with FDA are expected to stop manufacturing them
within 90 days and stop shipping the products within 180 days.
Companies that have not previously listed products subject to
today’s action with FDA are expected to stop manufacturing and
shipping their products immediately.
Given that so many cough, cold, and allergy drug products exist
that are FDA-approved prescription products or are appropriately
marketed OTC, taking an unapprov
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