Drug firm Granules India on Thursday said it has received marketing approval from the US health regulator for Potassium Chloride extended-release tablets, used for treatment of patients with hypokalemia. Hypokalemia is a condition when the potassium level in a patient’s blood is too low.
The approved product is bioequivalent to the reference listed drug K-Dur Granules has received marketing approval from the US Food and Drug Administration (USFDA) for Potassium Chloride extended-release tablets USP in the strengths of 10 mEq (750 mg) and 20 mEq (1500 mg), the company said in a BSE filing.
Priyanka Chigurupati, Executive Director of Granules Pharma said, This approval from Granules India, received within 10 months of filing reiterates our strength in the development of complex generics… We will be launching this product from our Gagillapur site in Hyderabad, India.
Granules now have a total of 34 abbreviated new drug application (ANDA) approvals from the USFDA (32 final approvals and 2 tentative approvals). Citing IQVIA Health data, Granules said Potassium Chloride extended-release tablets had US generic sales of approximately USD 204 million for the most recent 12 months ending in August 2020. Shares of Granules India were trading 0.34 percent lower at Rs 384.20 apiece on BSE.