MUMBAI, India, and NAPLES, Fla. – Global pharmaceutical leader Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL under the 505(b)(2) pathway.
Lupin's Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient in Eliquis® (apixaban) by Bristol Myers Squibb, and provides an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets.
“This tentative approval reflects our continued focus on developing differentiated medicines that address meaningful patient needs. Apixaban oral suspension expands the ways in which this important therapy could be administered, while reinforcing our commitment to building a differentiated portfolio,” said Vinita Gupta, CEO, Lupin.
After final approval, Lupin will manufacture the product at its Somerset, New Jersey, facility, leveraging the company’s U.S.-based manufacturing expertise to support high-quality standards and supply reliability.
To know more, visit www.lupin.com or follow on LinkedIn https://www.linkedin.com/company/lupin
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