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Sobi receives FDA approval for Orfadin capsules


Swedish Orphan Biovitrum 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.

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 restriction of tyrosine and phenylalanine.

“The approval for increased shelf life and extended out-of-refrigeration time may help make Orfadin an even more flexible treatment option,” says Jon Miller, President of the Network of Tyrosinemia Advocates (NOTA). “Continued treatment improvements like this may help to lessen the burden of HT-1 for patients and their families.”

“Sobi has a long-term commitment to improve the lives of people living with HT-1, and the modified storage recommendation is a further step in this journey”, says Bodil Jonason, Vice President Commercial Operations and Head of Global Brands at Sobi.