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Lupin receives USFDA nod to Azacitidine for Injection


Lupin receives USFDA nod to Azacitidine for Injection

Lupin’s Azacitidine for Injection, 100 mg Single-Dose Vial is a generic version of Celgene Corporation’s Vidaza.

Mumbai: Mumbai-based drugmaker, Lupin strengthens its complex generics portfolio in Injectables with the recent US Food and Drug Administration(FDA) approval. Pharma major Lupin announced that it 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.

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).

Also Read: Lupin gets USFDA tentative approval for generic tablets to treat Erectile Dysfunction

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, Lyophilised vials and Pre-filled Syringes (PFS). It received an EIR from the US FDA in December 2018.

Lupin develops and delivers a wide range of branded & generic formulations, biotechnology products and APIs globally.

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Source: self
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