announced today that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Feraccru®, Shield's lead product.
Feraccru® is already approved in the EU for iron deficiency treatment in adults and in Switzerland for iron deficiency in adults with inflammatory bowel disease, the company said.
Carl Sterritt, CEO of Shield Therapeutics, added: "News that the NDA has been validated and accepted for review by the FDA brings us a major step closer to Feraccru potentially being approved in the USA in 2019.”
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.
The company said the FDA will shortly confirm the expected target date in 2019 for completion of the NDA review and STX will provide a further update at that time.
Shares in STX were trading at 33.5p each on the day of the announcement
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