Novitium gets FDA nod for first Orfadin generic

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Novitium gets FDA nod for first Orfadin generic

By Sandra Levy - 09/04/2019
Novitium, a partner of Endo'subsidiary Endo Ventures, has received the Food and Drug Administration’s green light for nitisinone tablets. The product is the first approved generic of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).

Endo's operating company Par 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 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. We are proud to continue our tradition at Par of providing high quality, affordable medicines to patients," said Domenic Ciarico, executive vice president and chief commercial officer, sterile and generics.

Orfadin had a global market value of approximately $85 million over the last four quarters, according to Swedish Orphan Biovitrum.

"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."

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