Teva said it will begin shipping the product immediately. Named Mitoxantrone Hydrochloride Injection USP, the treatment will be indicated for use in combination with corticosteroids as initial therapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.
The drug will also be indicated for use with other approved products for the initial therapy of acute nonlymphocytic leukemia in adults.
The product is the AP-rated equivalent to Novantrone Injection produced by the Swiss biotech Serono. The product generated annual sales of approximately $75 million in 2005.
Specialty pharmaceutical Mayne Pharma has also been granted approval for its formulation of the Serono drug, to be called Mitoxantrone Injection, USP. Unlike Teva’s 2mg/mL formulation, Mayne has approval for multiple-dose presentations and will market the drug in 20mg, 25mg and 30mg formulas.