RM Pharma Gains Low-Dose HemiClor Approval

FDA has approved an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults. Chlorthalidone, a thiazide-like diuretic, has been approved and marketed over several decades, and until now, only higher-dose chlorthalidone tablets (25 mg and 50 mg) have been available in the U.S., according to the company.

The new low-dose option is intended to help clinicians better individualize therapy and potentially reduce the risk of dose-related side effects. “As noted in the approved prescribing information, metabolic adverse effects such as hypokalemia and hyperuricemia are dose-related; thus, a lower starting dose may help mitigate these risks when initiating treatment,” the company says. Studies have demonstrated that “stepped-care treatment strategies — which often began with 12.5 mg of chlorthalidone — were effective in reducing the risk of cardiovascular events,” it adds.