Lupin Receives US FDA Tentative Approval For Apixaban Oral Suspension 1.25mg/mL
Lupin Limited has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL.
Lupin |
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 by Bristol Myers Squibb. The product is intended to provide an alternative for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets.
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Management Commentary
Vinita Gupta, CEO of Lupin, said the tentative approval reflects the company's focus on developing differentiated medicines that address patient needs. Gupta added that the oral suspension expands administration options for this therapy and reinforces Lupin’s commitment to building a differentiated portfolio.
Manufacturing Location
Upon receiving final approval, Lupin plans to manufacture the product at its Somerset facility in New Jersey, U.S. The company stated that this leverages its U.S.-based manufacturing expertise to support quality standards and supply reliability.
Disclaimer: This story is based on company exchange filings and is for informational purposes only. Investors should evaluate risks before making decisions.
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