Novitium gets Orfadin generic equicalent approval from USFDA

Novitium Pharma, LLC, a partner of Endo’s subsidiary Endo Ventures Limited, received approval from the U.S. Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

Endo said it’s operating company Par Pharmaceutical, Inc. expects to distribute the product through specialty pharmacies beginning this month.

“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.

Brandon Rockwell, Senior Vice President of Business Development, said: “Novitium has a history of impressive development and execution skills and we are pleased to have several products under development with them. 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.”