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New Delhi, May 21 Oncology drug maker Dabur Pharma Ltd announced that the US Food and Drug Administration (USFDA) has granted final approval to the company’s Abbreviated New Drug Application (ANDA) to market its generic version of EMD Serono’s Novantrone (Mitoxantrone Hydrochloride) Injection used in the treatment for prostrate cancer.

This is the company’s fifth approval in the US after earlier approvals for Carboplatin, Paclitaxel, Epirubicin & Irinotecan.

Mitoxantrone, which had sales of over $30 million in the US, is also indicated in combination with other treatments in the initial therapy of acute non-lymphocytic leukemia.

Speaking on the occasion, Mr Ajay Kumar Vij, CEO, Dabur Pharma, said: “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.” The drug will be manufactured at the company’s UK facility.

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