Lupin Receives Tentative USFDA Approval for Apixaban Oral Suspension
Mumbai, Sept 28 (TNT): Global pharmaceutical major Lupin Limited on Monday announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL through the 505(b)(2) regulatory pathway.
The oral liquid formulation contains apixaban, the active ingredient in Bristol Myers Squibb’s Eliquis, and offers an alternative administration option for adult patients requiring anticoagulation therapy, including those who have difficulty swallowing tablets, the pharma company said in a release here.
“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 of Lupin.
Upon receiving final approval, the product will be manufactured at Lupin’s facility in Somerset, New Jersey, leveraging the company’s US-based manufacturing capabilities to support quality standards and supply reliability, the release added.
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