Alembic Pharma gets tentative USFDA nod for Dapagliflozin Tablets to improve glycemic control

The approved Dapagliflozin Tablets is therapeutically equivalent to the reference listed drug product Farxiga Tablets of AstraZeneca AB.

New Delhi: Drug firm Alembic Pharmaceuticals on Tuesday said it has received tentative approval from the US health regulator for Dapagliflozin Tablets, a medication that helps to reduce blood glucose levels.

The approved product is therapeutically equivalent to the reference listed drug product Farxiga Tablets of AstraZeneca AB.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Dapagliflozin Tablets in the strengths of 5 mg and 10 mg, Alembic Pharmaceuticals said in a BSE filing.

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"Dapagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus," the filing added.

Quoting IQVIA sales data, the company said, Dapagliflozin Tablets, have an estimated market size of USD 1.7 billion for 12 months, ending December 2018.

The company said it now has a total of 99 ANDA approvals (88 final and 11 tentatives) from the USFDA.

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