USFDA7 April 2026 at 01:01 pm
Aurobindo Pharma Receives USFDA Approval for Dapagliflozin Tablets, 5 mg and 10 mg
AI Summary
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg. These products will be launched immediately and are expected to have a market size of US$ 10.2 billion. Aurobindo Pharma, being one of the first ANDA applicants, is eligible for 180 days of shared generic drug exclusivity. The products will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the Company.
Key Highlights
- Aurobindo Pharma received USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mg
- The products are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB
- The approved product has an estimated market size of US$ 10.2 billion
- Aurobindo Pharma is eligible for 180 days of shared generic drug exclusivity
- The products will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the Company
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