Lupin gets FDA approval for Doxercalciferol Injection
New Delhi: Pharma major Lupin announced that it has received approval for its Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials from the United States Food and Drug Administration (FDA) to market a generic version of Sanofi Genzyme’s Hectorol Injection.
Lupin’s Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vial is the generic version of Genzyme’s Hectorol Injection. It is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials had annual sales of approximately USD 133 million in the US (IQVIA MAT September 2018).
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