Endo has received approval from the Food and Drug Administration to market a room temperature stable, AB-rated generic of Orfadin (nitisinone; Sobi, Inc) capsule.

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

Hereditary tyrosinemia type 1 (HT-1) is a rare metabolic disorder characterized  by elevated blood levels of the amino acid tyrosine. If left untreated, the disease can lead to serious complications including hepatic, renal and peripheral nerve damage.

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“We are pleased to offer this rare patient population suffering from HT-1 the first and only bioequivalent and therapeutically equivalent option to Orfadin capsules. Additionally, the product can be stored at room temperature which is an added convenience to patients,” said Domenic Ciarico, Executive Vice President and Chief Commercial Officer, Sterile and Generics at Par Pharmaceutical. “We are proud to continue our tradition at Par of providing high quality, affordable medicines to patients.”

Nitisinone Capsules will be distributed via specialty pharmacies in September 2019 by Par, an operating company of Endo. 

For more information visit endo.com or parpharm.com.