Swedish Orphan Biovitrum To Temporarily Withdraw New Drug Application For Orfadin® Oral Suspension In The US

STOCKHOLM, Sweden, Dec. 27, 2013 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to withdraw the company's New Drug Application for an oral suspension of Orfadin in the US. The decision to withdraw the current application is based on a request for further information by the US Food and Drug Administration (FDA) regarding the usability by the intended user population of the Orfadin oral suspension and the oral syringe to be included in the package.

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