Caplin Point Laboratories has informed that Press Release regarding receipt of final approval by our Subsidiary Caplin Steriles from the United States Food and Drug Administration (USFDA) for the 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.
The above information is a part of company’s filings submitted to BSE.