Lupin gets tentative USFDA approval for Doxycycline capsules

The drug firm said it has received approval from the US health regulator to market Doxycycline Capsules used to treat bacterial infections in the American market.

The global pharma major has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Doxycycline capsules, 40 mg.

Doxycycline is a generic equivalent of Oracea, 40 mg, of Galderma Laboratories, L.P. The drug is used to treat a certain type of skin condition called rosacea in adult patients.

Doxycycline capsules (RLD Oracea) had estimated annual sales of $215 million in the U.S. (IQVIA MAT September 2022).

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.

Shares of Lupin declined 0.13% to Rs 709.80 on Monday, 7 November 2022. The domestic stock market was shut on Tuesday, 8 November 2022, for a public holiday.

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