Bangladesh-based drugmaker gets FDA’s approval for its generic Bristol-Myers’s diabetes tablets

Bangladesh-based drugmaker Beximco has received approval for its Bristol-Myers Squibb’s (BMS) generic equivalent Glucophage XR tablets, Metformin from the US Food and Drug Administration (FDA).

These tablets are adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Annual sales for Glucophage XR in the US were $918 million for the twelve months ending 31 October 2016, according to IMS data. This is Beximco’s third Abbreviated New Drug Application (ANDA) approval since its first June 2015.

Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals Limited, said: “This marks our third US FDA product approval since November last year and clearly demonstrates our competitive in-house expertise, in particular, our strength in extended-release formulation. We expect to launch this product through our US distribution partner during the middle of 2017.”

Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the FDA in June 2015 and also the first in the country to export medicine to US.