Lupin Limited announces it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for apixaban oral suspension 1.25 mg/mL. The company says the product is an oral liquid formulation designed for adult patients who need anticoagulation therapy and may have difficulty swallowing tablets.
Lupin positions the approval as part of its focus on differentiated medicines intended to address specific patient administration needs. The suspension contains apixaban, the same active ingredient as in Eliquis, which is marketed by Bristol Myers Squibb. Lupin states that, upon final approval, it plans to manufacture the product at its Somerset facility in New Jersey to support quality and supply reliability.
Both outlets frame the FDA action as “tentative” rather than final, and they rely on the company’s disclosures. The reporting largely aligns on the formulation, intended patient use case, and manufacturing plan, with limited additional detail beyond Lupin’s stated rationale.
