Drug firm Caplin Point Laboratories Ltd on Thursday (October 23) said its subsidiary Caplin Steriles Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for nicardipine hydrochloride in 0.9% sodium chloride injection.

The approval covers 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) single-dose infusion bags, which are therapeutic equivalents to the Reference Listed Drug from Hikma International Pharmaceuticals LLC.

Nicardipine hydrochloride in 0.9% sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. According to IQVIA (IMS Health), the product had US sales of approximately $68 million for the 12-month period end

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