Strides Pharma Science Limited’s step-down wholly-owned subsidiary Strides Pharma Global Limited, Singapore, has received the approval for potassium chloride extended-release tablets from the United States Food & Drug Administration (US FDA).
The tablets, used to treat hypokalemia, will be available in 600 mg and 750 mg dosage. The condition hypokalemia occurs when blood’s potassium levels are too low. The US market for the tablets is around $60 million.
“There are three active players in the market (for the Potassium Chloride extended release tablets) and Strides is the first Indian generic company to get this approval,” said the company. Lupin Limited’s US subsidiary Gavis Pharmaceuticals and Glenmark had received the US drug regulator’s nod for potassium chloride extended release tablets in 2016 and 2017, respectively.
The product, which is a generic version of Klor-Con extended release tablets of Upsher-Smith, will be manufactured at Strides’ Bengaluru facility.
This is the second extended release product approval for Strides. The first approval was for potassium citrate extended release tablets, used to prevent kidney stones, in September 2017.
Extended release pills are formulated in such a way that the drug is released slowly over time. This has the advantage of taking tablets less often and fewer side effects, as the levels of the drug in the body are more consistent.
Strides current portfolio consists of 78 abbreviated new drug application filings with the US FDA of which 26 are pending approval.