Mumbai, Feb. 24 -- The approval covers Sodium Phosphates Injection USP in strengths of 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) single-dose vials. The product is a generic therapeutic equivalent of the Reference Listed Drug (RLD), approved under NDA 018892 and marketed by Hospira, Inc., USA.

Sodium Phosphates Injection is indicated as a source of phosphorus for addition to large volume intravenous fluids to prevent or treat hypophosphatemia in patients with limited or no oral intake. It is also used in the preparation of customised parenteral nutrition formulations when standard electrolyte or nutrient solutions are inadequate to meet patient requirements.

According to IQVIA (IMS Health) data, the approved strengths of Sodium...