GENERAL
Lupin Secures Tentative US FDA Nod For Novel Apixaban Oral Suspension
Lupin Ltd has received tentative approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Apixaban Oral Suspension 1.25 mg/mL through the 505(b)(2) regulatory pathway. The product is a liquid formulation of apixaban, the active ingredient in Bristol Myers Squibb’s Eliquis, and is designed to provide an alternative administration […]
