Lupin Gets Tentative USFDA Approval for Apixaban Oral Suspension
Mumbai: Lupin Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Apixaban Oral Suspension 1.25 mg/mL under the 505(b)(2) regulatory pathway, the company said.
Lupin's Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient in Eliquis (apixaban), and is intended to provide 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.
Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility, leveraging the company's US-based manufacturing capabilities to support supply of the product.
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence across India, the US, other developed markets and emerging markets. Its products are distributed in more than 100 markets.
The company's portfolio spans generics, complex generics, specialty medicines and biosimilars, with a presence across therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal and women's health.
Lupin operates 15 manufacturing facilities and six research centres, with a workforce of more than 26,000 professionals. The company also has operations spanning diagnostics, digital health, patient-support programmes and disease management initiatives.
