Aurobindo Pharma gets USFDA approval to market kidney ailment drug

The company will now market 800 gm Sevelamer Carbonate tablets

Aurobindo Pharma Limited announced on Wednesday that it has received the final approval from US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800 mg. 

Used to lower high blood phosphorus levels in patients who are on dialysis, Sevelamer Carbonate tablets are a therapeutic equivalent generic version of Genzyme's Renvela tablets.

The product, which is being launched immediately, is a significant event for the company as it has an estimated market size off $ 1.9 billion for the twelve months ending May 2017, according to IMS.

Besides being the first generic version of Sevelamer Carbonate approved by the US drug regulator.

According to the USFDA website, the approval for the Aurobindo's product was given on June 13, 2019.

This is the 124th ANDA (Abbreviated New Drug Application) to be approved out of Unit VII formulation facility in Hyderabad, according to Aurobindo. 

"Sevelamer Carbonate tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis," it said.