Caplin Steriles gets USFDA nod for hypertension injection

Chennai : Caplin Steriles Limited , a Subsidiary Company of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags. The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) 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), Nicardipine Hydrochloride in Sodium Chloride Injection had US sales of approximate