Lupin stock hits new high as Novel Laboratories gets USFDA approval for generic equivalent of Derma-Smoothe

9 Aug 2023 , 11:12 AM

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 (USFDA) for its Abbreviated New Drug Application (ANDA) for Fluocinolone Acetonide Oil, 0.01%, which is a Body Oil.

Following this development, Lupin’s counter touched a new 52-week high of Rs 1,109.

It is a generic version of Hill Dermaceuticals Inc.’s Derma-Smoothe/FS 0.01% (Body Oil).

The company stated that the product will be manufactured at Lupin’s Somerset facility situated in the United States.

In the United States, the estimated annual sales of Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS) was USD 10 million (IQVIA MAT June 2023).

At around 10.57 AM, Lupin was trading 1.28% higher at Rs 1,097.60 per piece, against the previous close of Rs 1,083.70 on NSE.

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