Endo reports FDA approval for first generic Orfadin
5 September 2019 -

Pharmaceuticals company Endo International plc (NASDAQ:ENDP) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for the first room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).

The approval was granted to Novitium Pharma LLC, a partner of Endo's subsidiary Endo Ventures Limited.

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

HT-1 is a rare and serious inherited metabolic disease caused by the inability to metabolise the amino acid tyrosine. Left untreated, HT-1 can cause hepatic, renal and peripheral nerve damage.

Endo's operating company Par Pharmaceutical Inc expects to distribute the Generic Orfadin through specialty pharmacies from this month.

In the last four quarters, global sales for Orfadin were approximately USD85m, according to Swedish Orphan Biovitrum.