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news.Dabur Pharma has announced that the FDA has granted final approval to the company's abbreviated new drug application to market its generic version of EMD Serono's Novantrone Injection 20mg, 25mg and 30mg.
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This is the company’s fifth approval in the US after earlier approvals for Carboplatin, Paclitaxel, Epirubicin & Irinotecan. Mitoxantrone is an antineoplastic agent used in combination with corticosteroids for the treatment of advanced hormone-refractory prostate cancer. It is also indicated in combination with other treatments in the initial therapy of acute nonlymphocytic leukemia.
Ajay Vij, CEO of Dabur Pharma: “The approval represents another key milestone for the company in the US market; strengthening not only our portfolio but also our confidence of achieving one of the leading position in the generic oncology space.”