Granules India gets USFDA nod for Potassium Chloride ER capsules
New Delhi: Drug firm Granules India on Wednesday said it has received approval from the US health regulator for its generic Potassium Chloride extended-release capsules that are used for the treatment of low blood potassium.
The US Food & Drug Administration (USFDA) has approved the company's abbreviated new drug application (ANDA) for Potassium Chloride extended-release capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg), Granules India said in a filing to BSE.
The product is a generic version of Nesher Pharmaceuticals (USA) LLC''s Micro-K extended-release capsules in the same strengths, it added. The capsules would be manufactured at the company's Hyderabad facility and are expected to be launched shortly, the filing said.
"We are pleased to announce the approval of Potassium Chloride Capsule product within the first review cycle of 10 months from the filing date. This is the fourth ANDA approval in our Potassium Chloride product basket", Granules Pharmaceuticals Inc Executive Director Priyanka Chigurupati said.
According to IQVIA Health, Potassium Chloride ER capsule products had US sales of approximately USD 43 million for the most recent twelve months ending in December 2020, Granules India said.
The company now has a total of 37 ANDA approvals from USFDA (36 Final approvals and 1 tentative approval), it added.
Potassium Chloride is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis, Granules India said. The product is also indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, it added.