Global pharma major Lupin Limited (Lupin) today announced that its wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, a generic equivalent of Diastat® AcuDialTM Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.
Diazepam Rectal Gel (RLD Diastat® AcuDialTM) had estimated annual sales of USD 34 million in the U.S. (IQVIA MAT Mar 2023).
About Lupin
Lupin 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.
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