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news.Endo International announced that Novitium Pharma, a partner of its subsidiary Endo Ventures, 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).
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
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Endo’s operating company Par Pharmaceutical, Inc. 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. “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.”
According to Swedish Orphan Biovitrum, global sales for Orfadin were approximately $85M over the last four quarters.
Source: Company Press Release
