Beximco Pharmaceuticals gets eighth FDA approval
Generic drugs manufacturer Beximco Pharmaceuticals has received US Food and Drug Administration (FDA) approval for flecainide acetate 50mg, 100mg and 150mg tablets), it announced on Monday.
The AIM-traded firm described flecainide acetate as an antiarrhythmic drug, used for treating irregular heartbeats in conditions such as tachycardia and atrial fibrillation.
It said it was its eighth abbreviated new drug application (ANDA) successfully approved for the US market since its oral solid dosage facility was approved by the FDA in June 2015.
The company expected to launch the product through its US distribution partner in due course.
Flecainide acetate is the generic equivalent to 3M Pharmaceuticals' ‘Tambocor’.
Beximco noted that, according to IQVIA audited market data, the total addressable market for flecainide acetate was approximately $50m (£38.91m) annually.
“This approval is another important step in building and strengthening our presence in the US market,” said managing director Nazmul Hassan.
“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.”
At 0957 BST, shares in Beximco Pharmaceuticals were up 3.36% at 56.85p.