GCIUS FDA Confirms Target Date For Completion Of Feraccru Review
announced today that the US Food and Drug Administration has confirmed that the target date for completion of the New Drug Application review of Feraccru is 27 July 2019, under the terms of the Prescription Drug User Fee Act.
The US represents over a third of the global pharmaceutical market. Shield retains full ownership of Feraccru® in US markets, as well as complete control of the global intellectual property rights.
Feraccru® is already approved in the European Union for the treatment of iron deficiency in adults and, following the recent licence agreement for Feraccru® in Europe, Norgine has now commenced its own sales and marketing activities, the company said.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics, added: "Confirmation of the PDUFA date for completion of the review of Feraccru® by the FDA is another important step towards being able to offer Feraccru® to the very large pool of iron deficient patients in the United States who would benefit from this novel new treatment option.”
“We will continue to work closely with the FDA to achieve this goal, whilst also seeking an attractive commercial partner for Feraccru in the USA who can help us realise the full value of the opportunity that would be created by Feraccru's approval."
Shares in STX were trading at 31.5p each on the day of the announcement
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