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| Sleep
Driving...Yikes! |
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FDA Requests Label Change for
All Sleep Disorder Drug Products
March 14, 2007 -- The U.S. Food and Drug
Administration (FDA) has requested that all
manufacturers of sedative-hypnotic drug products,
a class of drugs used to induce and/or maintain
sleep, strengthen their product labeling to
include stronger language concerning potential
risks. These risks include severe allergic
reactions and complex sleep-related behaviors,
which may include sleep-driving. Sleep driving is
defined as driving while not fully awake after
ingestion of a sedative-hypnotic product, with no
memory of the event.
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It's official! Our open
house to celebrate the completion of our building
will be Saturday, March 24th from
3:00-5:00 pm. We hope you received an Evite
from us with the details, but if you didn't please
email us and we will send it immediately. If you can
come, please RSVP. If you are
not able to attend but would like to have a tour
at another time, please let us know and we will
arrange
it.
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When Can We Start Accepting
Patients? |
As we explained in previous newsletters,
the Department of Children and Families ("DCF") is
the Florida agency that will license Novus. We have
submitted the required papers to the DCF and
expect a response by Thursday of this week. The DCF
has informed us that, subject to their review of
our package that it is possible that we will be
approved to start accepting patients by Friday,
March 23rd. If there
is additional information that the DCF requires,
this could delay us a few days but we are very
close to accepting our first
patients.
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