Lupin Gets US FDA Tentative Approval for Apixaban Oral Suspension

Generic drugmaker Lupin has received tentative approval from the US Food and Drug Administration for its Apixaban Oral Suspension 1.25mg/mL under the 505(b)(2) new drug approval pathway. The oral liquid formulation offers an alternative for adult patients needing anticoagulation therapy, including those who have difficulty swallowing tablets. Lupin will manufacture the product at its Somerset, New Jersey facility upon final approval.

Tip: use ↑ / ↓ (or j / k) to move between stories.