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Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Dapagliflozin.
Alembic Pharmaceuticals received final USFDA approval for generic Dapagliflozin Tablets in 5 mg and 10 mg.
KEY POINTS
- The approval allows Alembic to launch a generic version of AstraZeneca's Farxiga in the US market.
- Alembic is eligible for 180 days of shared generic exclusivity due to its early ANDA filing.
- The US market for this product is estimated at $10.5 billion for the year ending December 2025.
- Alembic's total USFDA approvals now stand at 235, including 217 final and 18 tentative approvals.
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