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Lupin Receives Tentative USFDA Approval for Apixaban Oral Suspension
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News18•28-09-2026, 10:30
Lupin Receives Tentative USFDA Approval for Apixaban Oral Suspension
- •Lupin announced it has received tentative approval from the US FDA for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL.
- •This drug offers an alternative administration option for adult patients needing anticoagulation therapy, especially those with difficulty swallowing tablets.
- •Apixaban Oral Suspension is an oral liquid formulation of apixaban, the active ingredient in Bristol Myers Squibb’s Eliquis.
- •Lupin CEO Vinita Gupta highlighted the company's focus on developing differentiated medicines that address significant patient needs.
- •Upon final approval, the product will be manufactured at Lupin’s Somerset facility in New Jersey, US.
Key Questions Answered
Lupin received tentative approval from the US Food and Drug Administration for Apixaban Oral Suspension 1.25 mg/mL via the 505(b)(2) pathway.
The oral suspension provides an alternative administration option for adult patients requiring anticoagulation therapy, including individuals who experience difficulty swallowing tablets.
Once final approval is granted by the USFDA, the product will be manufactured at Lupin's Somerset facility located in New Jersey, United States.
