Lupin Receives US FDA Tentative Approval For Apixaban Oral Suspension 1.25mg/mL
Mumbai: Lupin Limited on Monday, September 28, 2026, announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application (NDA) for Apixaban Oral Suspension 1.25mg/mL. Product Details Lupin’s Apixaban Oral Suspension 1.25mg/mL is an oral liquid formulation of apixaban, the active ingredient also found in Eliquis, a product…
On September 28, 2026, pharmaceutical company Lupin Limited announced that it had received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) regarding Apixaban Oral Suspension 1.25mg/mL. This product, produced by Lupin, is an oral liquid formulation of apixaban, the same active ingredient found in Eliquis, a medication by Bristol Myers Squibb.
The main purpose of this product is to offer an alternative treatment for adult patients who require anticoagulation therapy, particularly those who may struggle to swallow tablets.
Vinita Gupta, CEO of Lupin, expressed that the tentative approval from the FDA demonstrates the company's dedication to creating unique medicines that cater to patient requirements. She further highlighted that the oral suspension will provide additional administration options for this therapy, thereby strengthening Lupin's commitment to developing a diverse product portfolio.
Following the receipt of the final approval, the company plans to manufacture the product at its Somerset facility in New Jersey, USA. This decision is based on leveraging the company's manufacturing expertise in the U.S. to ensure adherence to quality standards and supply reliability.
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