At December 31, 2008 the following products were under development and the following section outlines their development status at February 27, 2009:
Treatments for ADHD
VYVANSE for ADHD in EU and Canada
In March 2008 the Canadian new drug submission was accepted for filing for the treatment of ADHD in children. Review is ongoing.
VYVANSE for the treatment of ADHD in children aged 6 to 17 in the EU is in Phase 3 development and Shire expects to submit the regulatory filing for VYVANSE in Europe in 2010.
DAYTRANA for ADHD in EU & Canada
Regulatory submissions were filed for approval of the product with Health Canada in November 2007 and in the EU via the decentralized procedure, with the Netherlands as the reference member state in December 2007. Reviews are ongoing.
INTUNIV for ADHD in US
In June 2007 Shire received an approvable letter from the FDA for INTUNIV. Shire is conducting additional clinical work which is designed to enhance the label. The New Drug Application ('NDA') was resubmitted in January 2009 and it is anticipated that launch for use in the treatment of ADHD in children and adolescents in the US will occur in the second half of 2009.
SPD487 (Amphetamine transdermal system)
In November 2008 Shire terminated the agreement with Noven Pharmaceuticals Inc. ('Noven') for the development of the amphetamine transdermal system.
Treatments for GI diseases
LIALDA/MEZAVANT for the maintenance of remission in ulcerative colitis in the US
Phase 3 trials investigating the use of the product to maintain remission
in patients who have ulcerative colitis were initiated in 2006 for the US
market and are continuing. The product was given this indication on app
|SOURCE Shire Plc|
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