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  • Diabetes Management:...

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

Farhat NasimWritten by Farhat Nasim Published On 2020-07-20T14:13:59+05:30  |  Updated On 20 July 2020 2:13 PM IST
Diabetes Management: Alembic Pharma gets tentative USFDA nod to Empagliflozin, Metformin Hydrochloride tablets
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The tentatively approved Empagliflozin and Metformin Hydrochloride tablets are therapeutically equivalent to Synjardy tablets of Boehringer Ingelheim Pharmaceuticals, Inc.

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 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

alembic pharmaalembic pharma newsdiabetes drugEmpagliflozinMetformin Hydrochloride tabletsmetforminBoehringer IngelheimSynjardy
Source : PTI
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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