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Cipla gets USFDA nod to market generic version of cancer drug Dacogen

It is indicated for treatment of patients with myelodysplastic syndromes

Press Trust of India  |  New Delhi 

Cipla's generic Dacogen gets USFDA go-ahead

Drug major has received final approval from the US health regulator for the generic version of Dacogen, indicated for the treatment of patients with myelodysplastic syndromes.

In a BSE filing on Monday, said, "It has received final approval for its abbreviated new drug application (ANDA) for Decitabine Injection 50 mg single-use sterile vial from the United States Food and Drug Administration (USFDA)."

The approved product is a generic equivalent of Otsuka America Pharmaceutical Inc's Dacogen. It is indicated f the treatment of patients with myelodysplastic syndromes (MDS), the company added.

Quoting IMS Health data, said Dacogen had US sales of approximately $180 million for the 12 months to September 2017.

The company said the approved product is available for shipping immediately.

stock was trading 1.42 per cent lower at Rs 600 on the BSE.

First Published: Mon, November 20 2017. 13:12 IST