Granules India Limited has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets, generic equivalent of Glumetza ER Tablets of Bausch Health US LLC (Bausch).
Metformin Hydrochloride ER Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Metformin Hydrochloride ER Tablets had US sales of approximately $192 million for the most recent 12 months ending in November 2020, according to IQVIA Health.
Granules now has a total of 35 ANDA approvals from US FDA (34 final approvals and one tentative approval).
Glumetza is a trademark of Salix Pharmaceuticals, Inc. or its affiliates, the Hyderabad-based Granules said in a release.