Global pharma major Lupin Limited (Lupin) 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 (FDA) for its Abbreviated New Drug Application for diazepam rectal gel, 10 mg and 20 mg, rectal delivery system, a generic equivalent of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.
Diazepam rectal gel (Diastat AcuDial) had estimated annual sales of USD 34 million in the US (IQVIA MAT March 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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
