Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 12, 2025, titled "Aurobindo Pharma receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg and tentative approval for other strengths of Rivaroxaban Tablets USP".
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Aurobindo Pharma has received final ANDA approval from the US FDA for Rivaroxaban Tablets USP in the 2.5mg strength, along with tentative approval for other strengths of the same drug. Rivaroxaban is a generic blood-thinning medication, commonly used to prevent and treat blood clots. ANDA (Abbreviated New Drug Application) approval allows the company to manufacture and market the generic version in the United States. The 2.5mg final approval means it can be launched immediately, while tentative approvals for other strengths allow launch once any existing patents or exclusivities expire.
This adds a new generic product to Aurobindo's US portfolio and opens up a revenue opportunity, as Rivaroxaban is a high-selling drug globally. The final approval for one strength enables immediate market entry, which could support US revenue growth going forward.