Vetoryl Receives Full FDA App
Issued by Citigate Dewe Rogerson Ltd, Birmingham
Date: Monday 15 December 2008
Dechra® Pharmaceuticals PLC
('Dechra' or 'the Group')
VETORYL® RECEIVES FULL FDA APPROVAL
Following disclosure in our preliminary results for the year ended 30 June 2008 that Dechra had received compliance notification on all parts of the dossier, the Directors are pleased to report that full FDA approval has now been received to market Vetoryl Capsules in the United States of America.
Vetoryl Capsules contain the drug Trilostane which has been demonstrated to be effective in the treatment of Cushing's syndrome in dogs. Vetoryl will be indicated for use in pituitary-dependent hyperadrenocorticism which comprises the majority of cases of Cushing's syndrome in dogs. Additionally, Vetoryl has received designation status as a Minor Use Drug for treatment of hyperadrenocorticism caused by adrenal tumours; the first drug to receive an approval for this indication and the first drug to receive a Minor Use designation in dogs in the United States.
Initial batches of product have been manufactured and are currently being shipped to the United States in preparation for the full launch in January 2009.
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Enquiries:
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Ian Page, Chief Executive
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Fiona Tooley, Director
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Simon Evans, Group Finance Director
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Keith Gabriel, Senior Account Manager
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Dechra Pharmaceuticals PLC
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Citigate Dewe Rogerson
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Mobile: +44 (0) 7775 642222 (IP)
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Mobile: +44 (0) 7785 703523 (FMT)
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or +44 (0) 7775 642220 (SE)
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or +44 (0) 7770 788624 (KG)
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Telephone: +44 (0) 1782 771100
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Telephone: +44 (0) 121 455 8370
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Notes to Editors
Vetoryl is a novel product for the treatment of Cushing's Disease (excess cortisol or hyperadrenocorticism) in dogs. It is marketed within the EU in 21 territories and is the only recognised licensed efficacious veterinary product for the treatment of Cushing's disease around the world. Launched in the UK on a provisional marketing authorisation in September 2001, Vetoryl has since achieved full approval in the EU and has consistently increased market penetration. Programmes have commenced to licence Vetoryl in Canada, Australia and Japan.
The US FDA ('Food and Drug Administration') Centre for Veterinary Medicine provides five years' protection from generic competitors for the first approval of a new pharmaceutical and seven years for a minor use designation, irrespective of its patent status.
Dechra and the Dechra 'D' logo are registered Trademarks of Dechra Pharmaceuticals PLC and Vetoryl is a registered Trademark of the Dechra Group.
This information is provided by RNS
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