Oakrum, Aucta gain FDA nod for generic Jadenu

Oakrum Pharma and Aucta Pharmaceuticals have received the Food and Drug Administration’s green light for a generic version of Novartis’ Jadenu  Sprinkle (deferasirox granules) in dosage strengths of 90 mg, 180 mg, and 360 mg.

Jadenu Sprinkle granules are used to treat people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions; and certain people 10 years of age or older, with thalassemia, who have an increased amount of iron in their blood but are not receiving regular blood transfusions.

"The investments that we have made in our product development pipeline since starting this business are expected to provide significant contributions to the growth of Oakrum Pharma over the next couple of years,” said Marco Polizzi, Oakrum CEO. “The launch of Deferasirox Granules is the first of several products that we expect to commercialize over the next 12-18 months.  A few of these near-term launches are products developed by Aucta Pharmaceuticals."

"We are excited to bring another Aucta Pharmaceuticals developed product to the U.S. market through this partnership with Oakrum Pharma," said Shoufeng Li, Aucta CEO. "Aucta Pharmaceuticals continues to expand its product portfolio in niche generics and branded specialty products and is anticipating additional approvals and launches in the next 12 months."

Deferasirox granules had a market value exceeding $31 million for the 12 months ending January 2021, according to IQVIA.