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Aurobindo Pharma has received the green light from the US Food & Drug Administration to produce and market its dapagliflozin tablets.
Aurobindo Pharma received FDA approval to produce generic dapagliflozin tablets for type 2 diabetes.
KEY POINTS
- The approved generic is bioequivalent and therapeutically equivalent to AstraZeneca's Farxiga.
- Aurobindo secured 180 days of shared generic marketing exclusivity for dapagliflozin in the US.
- The US market size for dapagliflozin is estimated at USD 10.2 billion as of February 2026.
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