Granules India gets USFDA nod to Metformin Hydrochloride ER tablets for diabetes management
New Delhi: Drug firm Granules India on Wednesday said it has received the US health regulator's approval for Metformin Hydrochloride extended-release (ER) tablets, used in the management of type-2 diabetes.
The approved product is the generic equivalent of Glumetza ER tablets, 500 mg and 1000 mg, of Bausch Health US LLC.
The US Food and Drug Administration (USFDA) has granted final approval for the company''s abbreviated new drug application (ANDA) for Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg, Granules said in a regulatory filing.
Quoting IQVIA health data, Granules said Metformin Hydrochloride ER tablets had sales of approximately USD 192 million in the US for the twelve months ending in November 2020.
Metformin Hydrochloride ER Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
The filing further said that Granules now has a total of 35 abbreviated new drug application (ANDA) approvals from USFDA (34 final approvals and 1 tentative approval).
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