Lupin arm Novel Labs bags USFDA nod for Diazepam Rectal Gel
Mumbai: Pharma major, Lupin Limited, has 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.
The product is a generic equivalent of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.
Diazepam Rectal Gel is used to stop cluster seizures in emergency situations in people, who are consuming other medications for the treatment of epilepsy (seizures).
Medical Dialogues team had earlier reported that Lupin Limited had launched Rufinamide Tablets USP, 200 mg and 400 mg in the United States market.
Read also: Lupin rolls out Seizure drug Rufinamide in US
Diazepam Rectal Gel (RLD Diastat AcuDial) had estimated annual sales of USD 34 million in the U.S. (IQVIA MAT Mar 2023).
Read also: Lupin gets USFDA nod for generic equivalent of Ocaliva Tablets
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 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.
Read also: Lupin arm gets Health Canada nod to market generic version of Spiriva for COPD
