BRIEF—Endo gains FDA nod for first generic Orfadin

Endo International says that partner Novitium Pharma has received approval from the US Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin(nitisinone capsules).

Endo's operating company Par Pharmaceutical expects to distribute the product through specialty pharmacies beginning this month.

Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

"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.

According to Swedish Orphan Biovitrum, global sales for Orfadin were around $85 million over the last four quarters.