2nd May 2014 08:51
LONDON (Alliance News) - Dechra Pharmaceuticals PLC said Friday that it had received approvals in the US and UK for one of its products for horses, and marketing approval to re-launch a product in the US.
The company received approval from the US Food and Drug Administration and the UK Veterinary Medicines Directorate for its product Osphos, used to treat navicular syndrome in horses.
The company noted that "in the majority of Europe, the horse is classed as a food producing species" which meant it had had to conduct additional studies to ensure food safety.
It also received marketing approval for the re-launch of sterile ophthalmic treatments Vetropolycin and Vetropolycin HC in the US, after they were transferred into a new manufacturing site.
Dechra noted that it has already manufactured the first stocks of the products ahead of the relaunch, although it noted that it does not expect the launch to have a material effect on its sales and profitability in the current financial year.
It has submitted a dossier for a canine endocrine product for approval in the EU, and will be submitting the dossier to the FDA. It is targeting approval for the product in the 2016 financial year.
Shares in Dechra were trading up 1.4% at 700.50 pence Friday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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