Storage Update for Orfadin Capsules

The new approval extends shelf life from 24 months to 36 months for certain capsule strengths
The new approval extends shelf life from 24 months to 36 months for certain capsule strengths

The Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Orfadin (nitisinone capsules; Sobi) which allows for an extension of shelf life for the 20mg capsules from 24 months to 36 months under refrigerated storage. It also allows in-use storage at room temperature for all strengths of Orfadin capsules for up to 45 days. 

Orfadin, a 4-hydroxyphenylpyruvate dioxygenase inhibitor, is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.  

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“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.”

Orfadin is available as 2mg, 5mg, 10mg, and 20mg strength capsules. It is also supplied as a 4mg/mL oral suspension.

For more information visit Sobi.com.