Lupin gets FDA approval for Sevelamer Carbonate for Oral Suspension

Lupin Limited said that it has secured approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Sevelamer Carbonate for Oral Suspension, 0.8 g and 2.4 g packets.

Sevelamer Carbonate is a generic equivalent of Renvela for Oral Suspension, 0.8 g and 2.4 g Packets of Genzyme.

Lupin said that the product will be manufactured at its Goa facility in India.

As per IQVIA MAT figures for September 2021, Sevelamer Carbonate for Oral Suspension (RLD: Renvela for Oral Suspension) had estimated $51.7 million per year in the US.