Caplin Point Laboratories’ subsidiary -- Caplin Steriles 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 IQVIATM (IMS Health), Procainamide hydrochloride Injection had US
sales of around $20 million for the 12-month period ending December 2024.
Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.
Source: Ace Equity