The US Food and Drug Administration (USFDA) has approved drugmaker Granules India’s Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg).
The product is bioequivalent to the reference listed drug Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA). A release from Granules said the product will be manufactured at the company’s Hyderabad facility and expected to be launched shortly.
Potassium Chloride is indicated for the treatment of hypokalemia. Potassium Chloride ER Capsule products had U.S. sales of around $43 million for the most recent twelve months ending in December 2020, the company said citing IQVIA Health numbers.
Executive Director Priyanka Chigurupati said the approval has come within the first review cycle of 10 months from the filing date. It is the fourth ANDA approval in Granules’ Potassium Chloride product basket. Granules now has a total of 37 ANDA approvals from USFDA (36 final approvals and 1 tentative approval), a release said.
