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Document Preview For Immediate Release |
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For Immediate Release |
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2001 |
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$31 |
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#324440 |
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{TEXT}
Shire Pharmaceuticals Group plc
Hampshire International Business Park,
Chineham, Basingstoke RG24 8EP UK
Tel +44 1256 894000 Fax +44 1256 894708
http://www.shire.com
(Company Logo)
For immediate release
Shire's Adderall XRTM receives FDA approval
Basingstoke, UK - 12 October 2001 - Shire Pharmaceuticals Group plc (LSE: SHP.L,
NASDAQ: SHPGY, TSE: SQ) announces today that the US Food and Drug Administration
(FDA) have approved Adderall XR(TM), the new once a day treatment for attention
deficit/hyperactivity disorder (ADHD). Adderall XR was developed by Shire
Laboratories Inc., using their proprietary Microtrol(R)technology and will be
launched imminently in the US.
Adderall XR, a novel formulation of Shire's US ADHD brand leader
Adderall(R)1,2,3, is designed to provide an all day treatment with one morning
dose. This is considered to be an increasingly important benefit for children
with ADHD and their caregivers, both at home and at school.
The FDA based its approval of Adderall XR on results of two studies, involving
over 600 patients at more than 50 sites. These studies determined that Adderall
XR substantially improved patients' ability to work, focus and learn by tackling
the most common ADHD symptoms, namely poor concentration, hyperactivity and
impulsivity. The effects of ADDERALL XR were shown to have a prompt onset of
action and to last throughout the day and into the late afternoon, a time when
many children participate in after-school activities, including homework.
With most other ADHD medications an additional dose must be taken during the
school day, or immediately after school, making teachers or the child
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