FDA approves in-use storage at room temperature for Orfadin® capsules
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that FDA has approved in-use storage at room temperature (25°C or less) for up to 45 days for all strengths of Orfadin® capsules (2 mg, 5 mg, 10 mg and 20 mg). The FDA approval follows the already existing approval by the European Medicines Agency (EMA) for in-use storage at room temperature. In addition to this, FDA also approved an extended shelf life for Orfadin capsules 20 mg, from 24 to 36 months. Orfadin is approved for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary