Alembic Pharma gets FDA tentative approval glycemic control drug

Alembic Pharma gets FDA tentative approval for glycemic control drug

9:21 AM, 24th July 2019
Alembic Pharma logo

VADODARA, INDIA: Alembic Pharmaceuticals Limited said that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Farxiga Tablets, 5 mg and 10 mg; of AstraZeneca AB (AstraZeneca).

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

Dapagliflozin Tablets have an estimated market size of $1.7 billion for twelve months ending December 2018 according to IQVIA. Alembic now have a total of 99 ANDA approvals (88 final approvals and 11 tentative approvals) from USFDA.

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