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Cipla gets US FDA marketing approval for generic Dacogen

Our Bureau, Mumbai
Monday, November 20, 2017, 12:30 Hrs  [IST]

Cipla Ltd, a global pharmaceutical company,  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 (FDA) to market generic version of Otsuka America Pharmaceutical Inc.’s Dacogen.

Cipla’s decitabine injection 50 mg/vial is AP-rated and is generic equivalent of Otsuka America Pharmaceutical Inc.’s, Dacogen. It is indicated for treatment of patients with myelodysplastic syndromes (MDS). The product is available for shipping immediately.

Dacogen and its generic equivalents had US sales of approximately $180 million for the 12-month period ending September 2017, as reported by IMS Health.


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