Beximco Pharma gets US FDA approval for Flecainide


Beximco Pharmaceuticals Limited on Monday announces it has received US Food and Drug Administration (FDA) approval for Flecainide Acetate (50, 100 and 150 mg tablets), an antiarrythmic drug used for treating irregular heartbeats in conditions such as tachycardia and artrial fibrillation.

This is BeximcoPharma’s eighth Abbreviated New Drug Application (ANDA) successfully approved for the US market since the Company’s oral solid dosage facility was approved by the US FDA in June 2015. The Company expects to launch the product through its US distribution partner in due course.

Flecainide Acetate is the generic equivalent to 3M Pharmaceuticals’ Tambocor® (50, 100 and 150 mg tablets). According to IQVIA audited market data, the total addressable market for Flecainide Acetate is approximately US$50 million (Moving Annual Total, June 2020). Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:

"This approval is another important step in building and strengthening our presence in the US market. We continue to leverage our core strengths in R&D and manufacturing to develop and deliver specialised generic products, not only in the US, but also in a global setting.”