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Swedish Orphan Biovitrum AB - FDA Approves in-use Storage at Room Temperature for Orfadin® Capsules

Swedish Orphan Biovitrum AB (publ)(Sobi(TM)) 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 t

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