<p>Drug firm Alembic Pharmaceuticals on Thursday said it has received tentative approval from the US health regulator for Empagliflozin and Linagliptin tablets, used for management of type-2 diabetes.</p>.<p>Empagliflozin and Linagliptin Tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</p>.<p>The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.</p>.<p>In a regulatory filing, Alembic Pharmaceuticals said it has received tentative approval from the US Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin tablets in the strengths of 10 mg/5 mg and 25 mg/5 mg.</p>.<p>Alembic Pharma said it is currently in litigation with Boehringer in District Court of Delaware and launch of the product will depend on litigation outcome.</p>.<p>Quoting IQVIA data, Alembic Pharma said Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of $244 million for 12 months ending June 2020.</p>.<p>Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative approvals) from USFDA.</p>.<p>Shares of Alembic Pharmaceuticals were trading 1.95 percent higher at Rs 1,010.10 apiece on the BSE.</p>
<p>Drug firm Alembic Pharmaceuticals on Thursday said it has received tentative approval from the US health regulator for Empagliflozin and Linagliptin tablets, used for management of type-2 diabetes.</p>.<p>Empagliflozin and Linagliptin Tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</p>.<p>The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.</p>.<p>In a regulatory filing, Alembic Pharmaceuticals said it has received tentative approval from the US Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin tablets in the strengths of 10 mg/5 mg and 25 mg/5 mg.</p>.<p>Alembic Pharma said it is currently in litigation with Boehringer in District Court of Delaware and launch of the product will depend on litigation outcome.</p>.<p>Quoting IQVIA data, Alembic Pharma said Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of $244 million for 12 months ending June 2020.</p>.<p>Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative approvals) from USFDA.</p>.<p>Shares of Alembic Pharmaceuticals were trading 1.95 percent higher at Rs 1,010.10 apiece on the BSE.</p>