FDA approves Strides Pharma's generic Renvela

Strides’ subsidiary, Strides Pharma Global, Singapore, has received the Food and Drug Administration’s clearance for Sevelamer Carbonate Tablets, 800 mg.

The product is the generic of Genzyme’s Renvela. 

Sevelamer Carbonate is a phosphate binder that helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.

[Read more: Strides Pharma obtains FDA OK for generic Prozac]

Sevelamer Carbonate Tablets, 800 mg, has a market value of $181 million, per IQVIA.

The approval strengthens the company's presence in the Sevelamer portfolio, complementing the existing approval of Sevelamer Carbonate Powder for Oral Suspension, which has a market value of $23 million, Strides said.  

Sevelamer tablets will be manufactured at the company’s facility in Puducherry.

[Read more: Strides Pharma obtains FDA clearance for generic Actigal]