Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by 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.
The product is 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.
Read also: Caplin Steriles gets USFDA nod for Levetiracetam in Sodium Chloride Injection, infusion bags
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