Sun Pharma receives US FDA approval for generic Glumetza

Sun Pharma has announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Glumetza, metformin hydrochloride extended release tablets 500 mg and 1000 mg.

These metformin hydrochloride extended release tablets are therapeutic equivalents of Santarus Inc.’s Glumetza tablets. As per IMS MAT June 2016, these tablets have annual sales of approximately US$ 1.2 billion in the US. The commercial launch of these tablets in the US is expected over the next few weeks.