Lupin receives approval from U.S. FDA for Diazepam Rectal Gel

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).

Shares of Lupin Limited was last trading in BSE at Rs. 811.50 as compared to the previous close of Rs. 804.55. The total number of shares traded during the day was 64659 in over 3117 trades.

The stock hit an intraday high of Rs. 816.90 and intraday low of 800.05. The net turnover during the day was Rs. 52565350.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 NovelLaboratories Approval USFDA ANDA DiazepamRectalGel