Beximco Receives US FDA Approval for Flecainide

Beximco Pharmaceuticals, the manufacturer of local generic pharmaceutical products and active pharmaceutical ingredients, has obtained another US Food and Drug Administration ( FDA ) approval, which is the eighth product to be exported to the American market by the company.

Approval for tablets of Flecainide Acetate 50 , 100 and 150 mg, which is an antiarrhythmic drug used in conditions such as tachycardia and atrial fibrillation to treat abnormal heartbeats, reports BSS.

The company plans to launch the product in due course through its US distribution partner, a statement said today.

Since the company's oral solid dosage facility was approved by the US FDA in June 2015, BeximcoPharma's Abbreviated New Drug Application (ANDA) has successfully been approved for the US market.

Nazmul Hassan, MP, Managing Director of Beximco Pharmaceuticals, said that this approval is another important step in building and improving the presence of the company 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.

The generic equivalent of 3 M Pharmaceuticals' Tambocor ® 50 , 100 and 150 mg tablets is Flecainide Acetate.

The total addressable market for Flecainide Acetate is approximately $ 50 million, according to audited market data from IQVIA.