From USFDA
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.
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