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).