Alembic Pharma gets USFDA tentative approval for Empagliflozin tablet

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Jardiance Tablets, 10 mg and 25 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Jan 15, 2020 06:01 IST India Infoline News Service

Alembic Pharmaceuticals
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin Tablets, 10 mg and 25 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Jardiance Tablets, 10 mg and 25 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Emapgliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Emapgliflozin Tablets have an estimated market size of US$ 3.4 billion for twelve months ending September 2019, according to IQVIA.

Further, Alembic has a cumulative total of 112 ANDA approvals (99 final approvals and 13 tentative approvals) from USFDA.

Stock view:
Alembic Pharmaceuticals Ltd is currently trading at Rs568 up by Rs6 or 1.07% from its previous closing of Rs562 on the BSE.

The scrip opened at Rs565 and has touched a high and low of Rs576.75 and Rs564.50 respectively.

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