New Delhi: Drug major Cipla 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, 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.