Beximco Pharmaceuticals Limited, a fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, has received the US Food and Drug Administration's (FDA) approval for flecainide acetate.
The company announced, Monday, that it received approval for flecainide acetate tablets – of 50, 100 and 150 mg – an antiarrhythmic drug used for treating irregular heartbeats in conditions such as tachycardia and atrial fibrillation, read a press release.
This is Beximco Pharma's eighth Abbreviated New Drug Application 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 audited market data by IQVIA, an American multinational company serving the combined industries of health information technology and clinical research, the total addressable market for flecainide acetate is approximately $50 million – as per the moving annual total in June 2020.
Nazmul Hassan, 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 and D and manufacturing to develop and deliver specialised generic products, not only in the US but also in a global setting."