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Cipla's generic Dacogen gets USFDA go-ahead

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

Published: 20th November 2017 11:07 AM  |   Last Updated: 20th November 2017 11:07 AM   |  A+A-

An employee works at the reception area of Cipla at its headquarters in Mumbai, India June 17, 2015. | Reuters

By PTI

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

In a BSE filing today, Cipla 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 for the treatment of patients with myelodysplastic syndromes (MDS), the company added. Quoting IMS Health data, Cipla said Dacogen had US sales of approximately USD 180 million for the 12 months to September 2017.

The company said the approved product is available for shipping immediately. The stock of Cipla was trading 1.42 per cent lower at Rs 600 on the BSE.

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