Media
Lupin Receives Tentative Approval from U.S. FDA for Rivaroxaban Tablets USP
Mumbai, Baltimore, January 23, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dronedarone Tablets USP, 400 mg, to market a generic equivalent of Multaq® Tablets, 400 mg of Sanofi-Aventis U.S. LLC. The product will be manufactured at Lupin’s Goa facility in India.
Rivaroxaban Tablets USP are indicated:
to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation
for treatment of deep vein thrombosis (DVT)
for treatment of pulmonary embolism (PE)
for reduction in the risk of recurrence of DVT or PE
for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients
to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)
to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD
for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years
for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure
Rivaroxaban Tablets USP (RLD Xarelto®) had estimated annual sales of USD 8,249 million in the U.S. (IQVIA MAT November 2023).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
Follow us on:
Twitter: https://twitter.com/LupinGlobal
LinkedIn: https://www.linkedin.com/company/lupin
Facebook: https://www.facebook.com/LupinWorld/
For further information or queries please contact –
Deputy General Manager – Corporate Communications
Xarelto®is the registered trademark of Bayer Aktiengesellschaft
Lupin Receives Tentative Approval from U.S. FDA for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets
Lupin Announces Closure of Inspection by U.S. FDA at its Somerset Facility with No Observations
Lupin Receives Approval from U.S. FDA for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06%
CloseSearch Product
