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).
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