Lupin Receives Tentative U.S. FDA Approval for Apixaban Oral Suspension
Lupin Limited received tentative U.S. FDA approval for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway. This oral liquid formulation offers an alternative for patients needing anticoagulation therapy. Manufacturing will occur at Lupin's New Jersey facility upon final approval.
The tentative approval of a new drug formulation, especially one that offers an alternative administration route for a commonly prescribed medication, can have a medium-term impact on the company's revenue and market presence in the U.S. pharmaceutical sector.
The tentative approval from the U.S. FDA for a new drug formulation is a positive development for the company, indicating progress in its product pipeline and market expansion.
Lupin Limited has announced that it 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. This approval is via the 505(b)(2) pathway.
Apixaban Oral Suspension is an oral liquid formulation of apixaban, the active ingredient in Eliquis® (apixaban) by Bristol Myers Squibb. It offers an alternative administration option for adult patients requiring anticoagulation therapy, particularly those who may have difficulty swallowing tablets.
Vinita Gupta, CEO of Lupin, stated that this tentative approval reflects the company's focus on developing differentiated medicines that address patient needs, expanding administration options for this important therapy and reinforcing their commitment to a differentiated portfolio.
Upon final approval, the product will be manufactured at Lupin's facility in Somerset, New Jersey, utilizing the company's U.S.-based manufacturing expertise to ensure high-quality standards and supply reliability. The announcement was made on September 28, 2026.
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