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Lupin receives USFDA’s approval for Decitabine for Injection

Lupin has received approval for its Decitabine for Injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (USFDA) to market a generic version of Otsuka Pharmaceutical Company’s (Otsuka) Dacogen for Injection, 50 mg/vial, Single-Dose Vial.

It is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection, 50 mg/vial, Single-Dose Vial had annual sales of approximately $135.9 million in the US (IQVIA MAT September 2018).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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