Sobi to temporarily withdraw New Drug Application for Orfadin® oral suspension in the US
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision towithdraw the company's New Drug Application for an oral suspension of Orfadin inthe US. The decision to withdraw the current application is based on a requestfor further information by the US Food and Drug Administration (FDA) regardingthe usability by the intended user population of the Orfadin oral suspension andthe oral syringe to be included in the package. Sobi will discuss a re-submission date for the Orfadin oral suspension with theFDA in Q1 2014. --- About OrfadinOrfadin is used for the treatment of