FDA gives target date for Shield's Feraccru application

(Sharecast News) - Commercial stage pharmaceutical company Shield Therapeutics announced on Thursday that the US Food and Drug Administration (FDA) has confirmed that the target date for completion of the New Drug Application (NDA) review of 'Feraccru', under the terms of the Prescription Drug User Fee Act, would be 27 July 2019.The AIM-traded firm said the United States, representing over a third of the global pharmaceutical market, was a "highly attractive" opportunity for Feraccru, and a market for which Shield retained full ownership of - as well as complete control over - the global intellectual property rights.It said Feraccru was 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 had now commenced its own sales and marketing activities."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," said Shield Therapeutics chief executive officer Carl Sterritt."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." Shield Thera