Diabetes Management: Alembic Pharma gets tentative USFDA nod to Empagliflozin, Metformin Hydrochloride tablets

New Delhi: Drug firm Alembic Pharmaceuticals on Monday said it has received tentative approval from the US health regulator for Empagliflozin and Metformin Hydrochloride tablets, used for the management of type-2 diabetes.

The tentatively approved product is therapeutically equivalent to Synjardy tablets of Boehringer Ingelheim Pharmaceuticals, Inc.

Alembic Pharma said it is currently in litigation with Boehringer Ingelheim in District Court of Delaware and the launch of the product will depend on litigation outcome.

Empagliflozin and Metformin Hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

Quoting IQVIA data, Alembic Pharma said Empagliflozin and Metformin Hydrochloride tablets have an estimated market size of USD 172 million for twelve months ending March 2020.

Alembic now has a total of 126 ANDA approvals (111 final approvals and 15 tentative approvals) from USFDA.

Also Read: Alembic Pharma, Lupin, Others Recall Products In US Market: USFDA Report