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Shield Therapeutics iron deficiency treatment accepted by FDA for review

Monday, 3rd December 2018
Shield Therapeutics said the US Food and Drug Administration had accepted for review a new drug application for its lead iron deficiency product.

The regulator would shortly confirm to Shield the expected target date in 2019 for completion of the application review, the company said.

The treatment, Feraccru, had already been approved in the European Union for the treatment of iron deficiency in adults, and in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease.

'We look forward to interacting positively with the FDA over the coming months and, if approved, Feraccru will provide a novel and much needed treatment option for patients with iron deficiency,' vice president of regulatory affairs and quality Jackie Mitchell said.

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