FDA Approves Prolonged Shelf Life and Storage Temperature for Orfadin

Sobi received FDA approval for the extension of the shelf life for 20mg Orfadin capsules, from 24 months to 36 months under refrigerated storage (2-8°C). The agency also approved in-use storage at room temperature (25°C or less) for all strengths of Orfadin capsules (2mg, 5mg, 10mg and 20mg) for up to 45 days.

Orfadin is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase indicated for use as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.