Caplin Steriles, a Subsidiary Company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRONESTYL, from Apothecon Inc.
Procainamide hydrochloride Injection is an antiarrhythmic medicine used to treat certain arrhythmia (abnormal heart rhythm). It restores normal heart rhythm by blocking abnormal electrical signals in the heart. According to IQVIA (IMS Health), Procainamide hydrochloride Injection had US sales of approximately $20 million for the 12-month period ending December 2024.