Lupin receives FDA approval for Azacitidine for Injection, 100 mg Single-Dose Vial

Deepthi | Myequity news | Date : 28-02-2019 16:30:00 IST

Pharma major Lupin has received approval for its Azacitidine for Injection, 100 mg Single-Dose Vial from the United States Food and Drug Administration (FDA) to market a generic version of Celgene Corporation’s Vidaza®. With this approval, Lupin strengthens its complex generics portfolio in Injectables.

Lupin’s Azacitidine for Injection, 100 mg Single-Dose Vial is a generic version of Celgene Corporation’s Vidaza®. It is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).


Azacitidine for Injection, 100 mg Single-Dose Vial had annual sales of approximately USD 112 million in the US (IQVIA MAT December 2018).

Lupin’s state-of-the-art Mihan facility at Nagpur commissioned recently has the production capabilities for injectables with vials, Iyophilised vials and Pre-filled Syringes (PFS). It received an EIR from US FDA in December 2018.

About Lupin Limited


Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.


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