Beximco Pharmaceuticals Limited has recently received US Food and Drug Administration approval for Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace, following submission of an Abbreviated New Drug Application in June 2014, said a news release.
This is the second product from Beximco Pharma to be approved by the US FDA after Carvedilol, a prescription drug for treating hypertension, in July 2015.
This approval will allow Beximco Pharma to produce Sotalol tablets in different strengths, ie 80 mg, 120 mg and 160 mg. The company expects to launch this product during the first quarter of 2017.
Nazmul Hassan, managing director of Beximco Pharmaceuticals said, ‘We are delighted to have received our second product approval from the US FDA.’
He said, ‘We are already exporting Carvedilol to the US and I firmly believe this approval, together with our growing pipeline, will help us to build our presence in the US pharmaceutical market in the coming years.’
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015.
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