Powered by

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

Sign up for unrestricted access to 200+ subscription services.
Already have an account? Click here to login.

RelSci News & Alerts gets you:

  • 5 free articles a month from top subscription outlets like the Financial Times, New York Times, and Washington Post
  • Competitive business intelligence through daily data updates
  • Custom feeds on target high-value individuals, companies, industries, and topics delivered straight to your inbox