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 company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Empagliflozin and Metformin Hydrochloride tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, Alembic Pharmaceuticals said in a regulatory filing.
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 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. Shares of Alembic Pharmaceuticals were trading 4.92 per cent higher at Rs 1,025 apiece on the BSE.