 "Image courtesy: Sun Pharma")
The US drug regulator has granted final approval to Sun Pharma for its diabetes drug metformin hydrochloride extended release (ER) tablets (500 mg and 1000 mg), which are therapeutic equivalents of Santarus Inc’s Glumetza tablets.
“One of the company’s subsidiaries has received final approval from US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic version of Glumetza, metformin hydrochloride extended release tablets 500 mg and 1000 mg,” said Sun Pharma in a press release.
As per IMS MAT June 2016, these tablets have annual sales of approximately $ 1.2 billion in the US. The commercial launch of metformin ER tablets, which used for the treatment of type 2 diabetes, in the US is expected over the next few weeks.
