The Food and Drug Administration (FDA) has approved new labeling for Nityr (nitisinone; Cycle Pharma) to include an updated administration procedure for infants.

The labeling now states that a caregiver may disintegrate the Nityr tablet in an oral syringe up to 24 hours before administration. “By increasing the time to administer the preparation of the suspension from 2 hours to 24 hours, we are giving families a full day to decide when is the right time for them to administer the medication to their children…,” said Peter Myrenfors, Chief Medical Officer, Cycle. “Moreover, disintegrating the tablets prescribed in an oral syringe, will allow an accurate dosing, avoiding possible risks of under or over dosing.”

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Nityr, a hydroxyphenyl-pyruvate dioxygenase inhibitor, is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. The product is supplied in 2mg, 5mg, and 10mg tablets. For patients who have difficulty swallowing, the tablets may be disintegrated in water and administered via oral syringe.

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