Endo Announces First Approval of Generic Orfadin in US

Endo International (NASDAQ;ENDP) has announced that Novitium Pharma, a partner of Endo’s subsidiary Endo Ventures, received approval from the US Food and Drug Administration for a generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

As quoted in the press release:

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. “We are proud to continue our tradition at Par of providing high quality, affordable medicines to patients.”

“Novitium has a history of impressive development and execution skills and we are pleased to have several products under development with them,” said Brandon Rockwell, Senior Vice President of Business Development. “This first time generic approval is another example of Par’s strategic investment in business development and execution on first-to-market and first-to-file products.”

Click here to read the full press release.