Alembic Pharmaceuticals Secures USFDA Approval for Generic Dapagliflozin Tablets
Alembic Pharma receives USFDA approval for generic dapagliflozin tablets
Business Standard
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Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic dapagliflozin tablets, which are used to manage blood sugar levels in adults with type-2 diabetes. The approval covers 5 mg and 10 mg strengths, allowing Alembic to market the drug with a 180-day exclusivity period.
- 01Alembic Pharmaceuticals received USFDA approval for generic dapagliflozin tablets.
- 02The approved strengths are 5 mg and 10 mg.
- 03Dapagliflozin helps control blood sugar levels in type-2 diabetes patients.
- 04Alembic is eligible for 180 days of shared marketing exclusivity.
- 05The drug is indicated to reduce heart failure hospitalization risks.
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Alembic Pharmaceuticals Ltd has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its generic version of dapagliflozin tablets, which are crucial for managing blood sugar levels in adults with type-2 diabetes. The approval pertains to the 5 mg and 10 mg strengths of the drug, which is therapeutically equivalent to AstraZeneca's Farxiga Tablets. Alembic was among the first applicants to submit a complete abbreviated new drug application (ANDA) with a paragraph IV certification for these strengths. With this approval, Alembic is entitled to 180 days of shared generic drug marketing exclusivity. Dapagliflozin is indicated not only for improving glycemic control but also for reducing the risk of hospitalization due to heart failure in adults with type-2 diabetes who have existing cardiovascular conditions or multiple risk factors.
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