Lupin bags USFDA approval for Fesoterodine Fumarate ER Tablets
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg, and 8 mg.
The product is a generic equivalent of Toviaz Extended-Release Tablets, 4 mg, and 8 mg, of Pfizer Inc. The product will be manufactured at Lupin’s facility in Goa, India.
Fesoterodine Fumarate Extended-Release Tablets, 4 mg, and 8 mg, (RLD Toviaz) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).
Medical Dialogues had earlier reported that Alembic Pharmaceuticals Limited had received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg, and 8 mg to treat overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Read also: Alembic Pharma Bags USFDA Nod For Fesoterodine Fumarate ER Tablets To Treat Overactive Bladder
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 specializes 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. The company invested 8.7% of its revenue in research and development in FY22.
Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
