Beximco Pharma receives second product approval from the US FDA

Beximco Pharmaceuticals (AIM: BXP) has received US Food and Drug Administration approval for sotalol hydrochloride, a generic version of the cardiovascular drug Betapace, originally developed by Bayer legacy company Schering AG and first approved in 1992, following submission of an Abbreviated New Drug Application (ANDA) in June 2014.

This is the second product from Beximco Pharma, largest manufacturer and exporter of generic and active pharmaceuticals ingredients in Bangladesh, to be approved by the US FDA after carvedilol, a prescription drug for treating hypertension, which was approved in July 2015.

This approval will allow Beximco Pharma to produce sotalol tablets in different strengths, ie, 80mg, 120mg and 160mg. The company expects to launch this product during the first quarter of 2017.