Lupin Gets U.S. FDA Tentative Approval for Apixaban Oral Suspension
We are pleased to enclose a Press Release titled “Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension”
Lupin Receives FDA Approval
Lupin Limited 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 product is an oral liquid formulation of apixaban, the active ingredient in Eliquis®, which is used as an anticoagulant. The suspension provides another administration option for adult patients who may have difficulty swallowing tablets.
Product Details
- Product: Apixaban Oral Suspension 1.25 mg/mL
- Active Ingredient: Apixaban
- Dosage Form: Oral suspension
- Market: United States
- Regulatory Pathway: 505(b)(2)
- FDA Status: Tentative approval
What to Watch Next
Investors may track the final FDA approval, commercial launch timeline and manufacturing plans for Apixaban Oral Suspension in the U.S. market.
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