Indian Based Strides Shasun gets FDA nod for potassium citrate ER – Kidney Stone Tablets

Strides Shasun said it has received approval from US FDA for potassium citrate extended release tablets known to prevent certain types of kidney stones.  In a BSE filing, Strides Shasun has announced that it has received approval from United States FDA.

The potassium citrate extended release tablet USP 5mEq, 10mEq and 15 mEq has received the nod. According to Strides Shasun, it will be the second generic player in the market to commercialize this product and is planning to launch it immediately.

Before Strides Shasus, Zydus Cadila has received the nod for the manufacturing and marketing of potassium citrate drug three years ago. In the year 2014, Zydus Cadila has also received the final approval from US FDA to market the Potassium citrate ER tablets that can prevent kidney stones.

Zydus Cadila also marketed potassium citrate in the strengths of 5 mEq, 10 mEq and 15 mEq. The estimated sale of potassium citrate ER tablets in the year 2014 is USD 131.7 million as per IMS. Whereas, citing IMS sales data, Strides Shasun said the US market for the approved product is around USD 110 million.


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