Bangladesh-based Beximco, the largest country’s pharmaceutcals exporter, has received its another US FDA product approval.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals. Image: Beximo
Namely, the approval for Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace.
This happens after the Abbreviated New Drug Application (ANDA) in June 2014, and is the second product from Beximco Pharma to be approved by the US FDA.
The first FDA approved medicine was Carvedilol, a prescription drug for treating hypertension, which was approved in July 2015.
Beximco Pharma said on Tuesday that this approval would allow to produce Sotalol tablets in different strengths, i.e. 80 mg, 120 mg and 160 mg. The company also expects to launch this product during the first quarter of 2017.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:
“We are delighted to have received our second product approval from the US FDA. Sotalol was fully developed in-house and this approval demonstrates our continued focus on strengthening capabilities, especially our competitive R&D and regulatory skills. 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.”