Lupin gains after new drug approval from US FDA

The pharma major said that its New Jersey-based subsidiary Novel Laboratories has received approval from the US FDA for its abbreviated new drug application for fluocinolone acetonide oil.

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Shares of Lupin Ltd gained over 1 percent to Rs 1095.50 on August 9 at 10.44 am after the company announced that it has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug.

The pharma major said that its New Jersey-based subsidiary Novel Laboratories Inc has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application for fluocinolone acetonide oil, a generic equivalent of DermaSmoothe/FS, of Hill Dermaceuticals Inc.

Fluocinolone acetonide oil, a body oil used to treat eczema a skin condition, had estimated annual sales of $10 million in the US as per IQVIA MAT June 2023.

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Earlier this month, Lupin Ltd. recorded a consolidated net profit of Rs 453.33 crore for the April-June quarter FY24, as against a consolidated net loss of Rs 86.8 crore reported in the same period a year ago.

The drugmaker’s net profit for the period topped the analyst’s estimate of Rs 276.2 crore. The Mumbai-based drugmaker also reported a 28.6 percent increase in revenue at Rs 4,814.06 crore as against Rs 3,743.8 crore in the year-ago period.

The company reported EBITDA of Rs 879.1 crore, compared to Rs 237.9 during the same period a year ago. EBITDA margins were 18.5 percent in the quarter, up 1190 basis points compared with the same period a year ago.

Lupin shares have been among the best performers in the pharma sector, gaining 64.31 per cent compared to a 22.38 percent rise in the BSE Healthcare Index.

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