Alembic Pharmaceuticals Secures USFDA Approval for Dapagliflozin Tablets
Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mg
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Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Dapagliflozin Tablets (5 mg and 10 mg), a treatment for adults with type 2 diabetes. This approval allows Alembic to benefit from 180 days of shared generic drug exclusivity in a market projected to reach $10.5 billion by December 2025.
- 01Alembic Pharmaceuticals received USFDA approval for Dapagliflozin Tablets.
- 02The tablets are indicated for adults with type 2 diabetes and cardiovascular risks.
- 03Alembic is eligible for 180 days of shared generic drug exclusivity.
- 04The market for Dapagliflozin tablets is estimated at $10.5 billion by December 2025.
- 05Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
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Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Dapagliflozin Tablets in 5 mg and 10 mg dosages. This approval is for the Abbreviated New Drug Application (ANDA) that is therapeutically equivalent to AstraZeneca's Farxiga Tablets. Dapagliflozin is indicated for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus, particularly those with established cardiovascular disease or multiple risk factors. Additionally, it is used to improve glycemic control in conjunction with diet and exercise. Alembic was among the first to submit a complete ANDA with a paragraph IV certification for these tablets, granting it 180 days of shared generic drug exclusivity. The market for Dapagliflozin tablets is projected to reach $10.5 billion by December 2025, highlighting the significant demand for this medication.
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The approval of Dapagliflozin Tablets will likely increase access to affordable diabetes medications, potentially lowering treatment costs for patients.
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