These are generic equivalent of Bristol-Myers Squibb’s Glucophage XR tablets, 500mg and 750mg.
Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Annual sales for Glucophage XR in the US was $918 million for the twelve months ending October 2016, according to IMS data. This is Beximco’s third ANDA or generic drug approval in USA since the company’s oral solid dosage facility was approved by the US FDA in June 2015.
Speaking on the approval, lawmaker Nazmul Hassan, managing director of Beximco Pharma, said: “We are glad to receive our 3rd product approval for the US market and this clearly demonstrates our competitive in-house capabilities, especially our strengths in extended-release formulation.”
“We expect to launch this product sometime in the middle of 2017.”
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015 and also the first in the country to export prescription medicine to America.
Thursday, March 27, 2025
