Instant Report

Date: 18-Feb-2021

Granules India Receives US FDA Approval For Generic Micro-K ER Capsules

Granules India Limited announced that the US Food & Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for potassium chloride extended-release capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg).

It is bioequivalent to the reference listed drug product (RLD), Micro-K extended-release capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at our Hyderabad facility and is expected to be launched shortly.

"We are pleased to announce approval of potassium chloride capsule product within first review cycle of 10 months from filing date. This is fourth ANDA approval in our potassium chloride product basket." said Priyanka Chigurupati, executive director, Granules Pharmaceuticals, Inc., commenting on the approval.

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. It is also indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states.

Granules has a total of 37 ANDA approvals from US FDA (36 final approvals and 1 tentative approvals).

Potassium chloride ER capsule products had US sales of approximately $43 million for the most recent twelve months ending in December 2020 according to IQVIA Health.