Posted by Michael Wonder on 04 Dec 2018
Shield Therapeutics announces the new drug application for Feraccru has been accepted for filing and review by the FDA
3 December 2018 - Shield Therapeutics today announces that the US FDA has accepted for review the new drug application for Feraccru, Shield’s lead product.
Under the terms of the Prescription Drug User Fee Act, the FDA will shortly confirm to Shield the expected target date in 2019 for completion of the review and Shield will provide a further update at that time.
In September 2018, Feraccru was licensed to Norgine in all European territories not already partnered as well as Australia and New Zealand.
