USFDA approves Strides Pharma’s potassium chloride oral solution for marketing in the US
Strides Pharma’s step-down subsidiary has recently received the USFDA’s[1] approval for one of its products. The US health regulator approved the company’s potassium chloride for oral solution. This news was shared by Strides Pharma Global, Singapore, on 15 March 2021 [1].
Potassium chloride for oral solution is used to prevent and treat low levels of potassium in the blood. This product, manufactured by Strides Pharma, is bioequivalent to the reference listed drug ( RLD ). The therapeutic equivalent of this product that is an RLD is called Potassium Chloride for Oral Solution USP[2], 20 mEq. This RLD is manufactured by Pharma Research Software Solution, LLC[3].
Per the IQVIA[4] moving annual total ( MAT ) January 2021 data, the company claimed that the US[5] market for this product was over USD[6] 6 million.
The pharma major has stated that this product will be manufactured in its facility in Bengaluru, India. Strides Pharma will do the marketing of this product in the US market.
Strides Pharma’s potassium chloride
Over 127 cumulative ANDA[7] fillings of this company have been submitted to the USFDA to date. Of this, over 100 ANDAs have been approved, while the remaining 27 are pending approval.
Potassium chloride for oral solution is used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis. This occurs in patients for whom the management of potassium-rich food in the diet or diuretic dose reduction is insufficient.
Abbreviation :
- 1. United States Food and Drug Administration.
- 2. United States Pharmacopoeia
- 3. Limited liability company
- 4. Formerly Quintiles and IMS Health, Inc.
- 5. United States
- 6. United States Dollar
- 7. Abbreviated New Drug Application