Dr Reddy’s Laboratories Ltd has launched paricalcitol injection in three strengthens - 2 mcg, 5 mcg & 10 mcg – in the US following the marketing approval received by the company from the US Food & Drug Administration (FDA).
The approved product, a synthetically manufactured vitamin D analog, is the generic version of Abbvie Inc’s Zemplar injection. According to IMS Health, the Zemplar brand and generic had US sales of approximately $ 22.5 million MAT for the most recent twelve months ending in July 2016.
Dr Reddy’s paricalcitol injection is the first ANDA product launched in the US market.
Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease stage 5.