Local generic pharmaceutical products and active pharmaceutical ingredients manufacturer, Beximco Pharmaceuticals has received another US Food and Drug Administration (FDA) approval which is company’s eighth product to be exported to American market.
The approval for Flecainide Acetate 50, 100 and 150 mg tablets which is an antiarrythmic drug used for treating irregular heartbeats in conditions such as tachycardia and atrial fibrillation.
The Company expects to launch the product through its US distribution partner in due course, said an announcement today.
BeximcoPharma’s this 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.
Beximco Pharmaceuticals Managing Director Nazmul Hassan, MP said this approval is another important step in building and strengthening company’s presence in the US market.
“We continue to leverage our core strengths in R&D and manufacturing to develop and deliver specialized generic products, not only in the US but also in a global setting,” he added.
Flecainide Acetate is the generic equivalent to 3M Pharmaceuticals’ Tambocor® 50, 100 and 150 mg tablets.
According to IQVIA audited market data, total addressable market for Flecainide Acetate is approximately $50 million.
